HIM 2433 MDC Reporting Adverse Reaction Question

HIM 2433 MDC Reporting Adverse Reaction Question

Sample Answer for HIM 2433 MDC Reporting Adverse Reaction Question Included After Question

Description

Read the instructions associated with the form for adverse reactions. You will note that the form indicates that the patient had an adverse reaction to a drug.

Your job is to review the health record document, determine, and report the adverse reaction. Pay close attention to what is required of D1 & D4. Put your name in textbox “G” as the reporter.

DISCHARGE SUMMARY
PATEL, SHERRY #0267852
DATE OF
ADMISSION: 02/26/XX DATE OF DISCHARGE: 03/01/XX
FINAL DIAGNOSES:
1. Left femoral neck fracture
2. Paroxysmal Atrial Fibrillation, converted
to sinus rhythm
3. Urinary tract infection
4. Rash due to Bactrim
5. Mild Dementia
6. Hypertensive Heart Disease with
hypercholestrolemia
7. History of Strokes (Cerebrovascular
Accidents [CVA])
Justification of Admission
This 77–year–old female presented to the ER after falling at her beach
home. Upon examination, the patient complains of inability to walk and severe
hip pain. Her past medical history reveals multiple strokes with dementia
residuals and heart disease. X–rays revealed a femoral neck fracture. Patient
current medications include Coumadin, Diovan, OsCal, Magnesium chloride,
Megace, Levothroid, Remeron, and Lipitor.
Hospital Course
The patient was admitted and Dr. Black an Orthopedic surgeon was consulted.
On the evening of 02/26, an open reduction and internal fixation repair was
performed on the left hip. During the surgery there was a great deal of blood
loss that was replaced with three units of packed cells. The patient transfused
two units packed cells without incidence. Coumadin was placed on hold and the
patient was placed on Lasix.
Postoperatively the patient developed an atrial fibrillation which was controlled
with Toprol, Digoxin, and Verapamil. Three days postoperatively, the patient
begin to spike fevers of 101 ̊. Cultures were taken of the blood and urine. The
patient developed a urinary tract infection growing over 100,000 colonies of E.
Coli bacteria. The patient was started on Bactrim p.o. however the patient
complained of a rash over her mid–abdomen. Calamine lotion was applied to the
rash using cotton swabs. The medication was switched to Keflex. The patient is
afebrile and currently receiving physical therapy. She will be transferred to
Miami Dade College Rehab Center where she will continue her therapy.

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Discharge Medications
The patient will be discharged to rehab with Lactulose 60 mg p.r.n. q.h.s.,
Darvocet 1 tablet q..6h p.r.n., Lovothroid 0.075 mg q.d., Lipitor 10 mg q.d.,
Remeron 15 md q.hs., OsCal 500+D 1 t.i.d., Coumadin 3 mg q.d., Diovan 160
mg q.d., Magnesium chloride 400–1 t.i.d., Neutra–Phos 1 tab q.i.d., Megace 100
mg q.i.d., Toprol 50–mg q.d.
Mark J. Curry, MD__ Mark J. Curry, MD
Attending Physician

Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The FDA Safety Information and Adverse Event Reporting Program Form FDA 3500 Form Approved: OMB No. 0910-0291, Expires: 06-30-2025 See PRA statement on page 6. FDA USE ONLY Triage unit sequence # FDA Rec. Date For VOLUNTARY reporting of adverse events, product problems and product use/medication errors Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month abbreviation, and 4-digit year; for example, 01-Jan-1900. A. PATIENT INFORMATION 1. Patient Identifier (In confidence) 3a. Sex: Enter the patient’s sex at birth (the sex that a person has or was assigned to at birth). Male Undifferentiated Female Decline to answer 4. Weight 2. Age or Date of Birth (e.g., 01-Jan-1900) Year(s) Week(s) Month(s) Day(s) 3b. Gender: Enter the patient’s current gender (how the patient thinks of themself). lb 5. Ethnicity (Check one) Hispanic/Latino kg Not Hispanic/Latino Cisgender man/boy (gender corresponds with birth sex) Transgender woman/trans woman/ male-to-female (MTF) Cisgender woman/girl (gender corresponds with birth sex) Other gender category; please specify: Transgender man/trans man/ female-to-male (FTM) Decline to answer 6. Race (check all that apply) American Indian/Alaska Native Asian Black or African American Native Hawaiian/ Other Pacific Islander White B. ADVERSE EVENT, PRODUCT PROBLEM 1. Type of Report (check all that apply) 2. Outcome Attributed to Adverse Event (check all that apply) Adverse Event Death – Date of death (e.g., 01-Jan-1900): Product Use/Medication Error Life-threatening Product Problem (e.g., defects/malfunctions) Hospitalization (initial or prolonged) Required Intervention to Prevent Permanent Impairment/Damage Problem with Different Manufacturer of Same Medicine Other Serious or Important Medical Events Congenital Anomaly/Birth Defects Disability or Permanent Damage 3. Date of Event (e.g., 01-Jan-1900) 4. Date of this Report (e.g., 01-Jan-1900) 5. Describe Event, Problem or Product Use/Medication Error Characters Remaining (max. 4,000): (field continues on next page) Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event. * Please see instructions Form FDA-3500 (11/22) Page 1 of 6 PSC Publishing Services (301) 443-6740 EF 6. Relevant Test/Laboratory Data Date (e.g., 01-Jan-1900) Relevant Test/Laboratory Data Additional comments Date (e.g., 01-Jan-1900) Characters Remaining (max. 2,000): 7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, tobacco product use, liver/kidney Characters Remaining (max. 2,000): problems, etc.) Form FDA-3500 (11/22) Page 2 of 6 (continued on next page) C. PRODUCT AVAILABILITY 1. Product Available for Evaluation? (Do not send product to FDA) No Yes Returned to Manufacturer on (e.g., 01-Jan-1900) 2. Do you have a picture of the product? (Check if you are including a picture) Yes D. SUSPECT PRODUCTS SUSPECT PRODUCT #1 This report involves: Cosmetic Dietary supplement Food/medical food Other 1. Name, Strength, Manufacturer/Compounder (from product label). Strength Product Name NDC # or Unique ID Unit Manufacturer/ Compounder Name 2. Dose or Amount Unit Lot # Frequency Route Other Frequency Other Route 3. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.) Unit OR Duration Therapy started on Therapy stopped on Dose reduced on (e.g., 01-Jan-1900) (e.g., 01-Jan-1900) (e.g., 01-Jan-1900) Is therapy still on-going? Yes No 4. Diagnosis for use (indication) 5. Product Type (check all that apply) 6. Expiration Date (e.g., 01-Jan-1900) OTC Compounded 7. Event Abated after use Stopped or Dose Reduced? Yes No This report involves: 8. Event Reappeared after Reintroduction? Yes Doesn’t apply SUSPECT PRODUCT #2 Cosmetic Generic Biosimilar Dietary supplement No Doesn’t apply Food/medical food Other 1. Name, Strength, Manufacturer/Compounder (from product label). Strength Product Name NDC # or Unique ID Unit Manufacturer/ Compounder Name 2. Dose or Amount Unit Lot # Frequency Route Other Frequency Other Route 3. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.) Unit OR Duration Therapy started on Therapy stopped on Dose reduced on (e.g., 01-Jan-1900) (e.g., 01-Jan-1900) (e.g., 01-Jan-1900) Is therapy still on-going? Yes No 4. Diagnosis for use (indication) 5. Product Type (check all that apply) 6. Expiration Date (e.g., 01-Jan-1900) OTC Compounded 7. Event Abated after use Stopped or Dose Reduced? Yes Form FDA-3500 No Doesn’t apply (11/22) Generic Biosimilar 8. Event Reappeared after Reintroduction? Yes Page 3 of 6 No Doesn’t apply (continued on next page) E. SUSPECT MEDICAL DEVICE 1. Brand Name 2a. Common Device Name 2b. Procode 3. Manufacurer Name, City and State 4. Model # Lot # Catalog # Expiration Date (e.g., 01-Jan-1900) Serial # Unique Device Identifier (UDI) # 5. Operator of device Health Professional Patient/Consumer Other 6a. If Implanted, Give Date (e.g., 01-Jan-1900) 6b. If Explanted, Give Date (e.g., 01-Jan-1900) 7a. Is this a single-use device that was reprocessed and reused on a patient? No Yes 7b. If Yes to Item 7a, Enter Name, Address of Reprocessor 8. Was this device ever serviced by a third-party servicer? Yes No Unknown F. OTHER (CONCOMITANT) MEDICAL PRODUCTS 1. Product names and therapy dates (Exclude treatment of event) Product Name Therapy Start Date (e.g., 01-Jan-1900) Therapy End Date (e.g., 01-Jan-1900) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Form FDA-3500 (11/22) Page 4 of 6 (continued on next page) G. REPORTER (See confidentiality section on next page) 1. Name and Address First Name Last Name Address City State/Province/Region ZIP/Postal Code Country Phone # Email 2. Health Professional? 3. Occupation Yes 4. Also Reported to: Manufacturer/Compounder No User Facility Distributor/Importer 5. If you do NOT want your identity disclosed to the manufacturer, please mark this box: ADVICE ABOUT VOLUNTARY REPORTING Detailed instructions available at: https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500 Report even if: Report adverse events, product problems or product use errors with: • You’re not certain the product caused the event • Medications(drugs or biologics) • You don’t have all the details • Medical devices (including diabetes glucose-test kit, • Just fill in the sections that apply to your report hearing aids, breast pumps, and many more) How to report: • Combination products(medication & medical devices) • Use section D for all products except medical devices • Blood transfusions, gene therapies, and human cells • Attach additional pages if needed and tissue transplants (for example, tendons, bone, • Use a separate form for each patient and corneas) • Report either to FDA or the manufacturer (or both) • Special nutritional products(dietary supplements, How to submit report: medical foods, infant formulas) • To report by phone, call toll-free: 1-800-FDA (332)• Cosmetics (such as moisturizers, makeup, shampoos 1088 and conditioners, face and body washes, deodorants, • To fax report: 1-800-FDA (332)-0178 nail care products, hair dyes and relaxers, and • To report online: www.fda.gov/medwatch/report.htm tattoos) • Food (including beverages and ingredients added to If your report involves a serious adverse event with a foods) device and it occurred in a facility outside a doctor’s Report product problems – quality, performance or office, that facility may be legally required to report to safety concerns such as: FDA and/or the manufacturer. Please notify the person • Suspected counterfeit product in that facility who would handle such reporting. • Suspected contamination Where to submit adverse events related to the following • Questionable stability products: • Defective components • If your report involves an animal drug, device, pet • Poor packaging or labeling food and livestock feed problems, go to • Therapeutic failures (product didn’t work) http://www.fda.gov/vetproductreporting Report SERIOUS adverse events. An event is serious • If your report involves a health problem or a product when the patient outcome is: problem with a tobacco product, go to • Death https://www.safetyreporting.hhs.gov or call • Life-threatening 1-877-287-1373 to report. • Hospitalization (initial or prolonged) • If your report involves an adverse event with a • Disability or permanent damage vaccine, go to http://vaers.hhs.gov to report or call • Congenital anomaly/birth defect 1-800-822-7967. • Required intervention to prevent permanent impairment or damage • Other serious (important medical events) Form FDA-3500 (11/22) Page 5 of 6 Confidentiality: The patient’s identity is held in strict confidence by FDA and protected to the fullest extent of the law. The reporter’s identity, including the identity of a self-reporter, may be shared with the manufacturer unless requested otherwise. Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov The information in this box applies only to requirements of the Paperwork Reduction Act of 1995 Please DO NOT RETURN this form to the PRA Staff e-mail above. The burden time for this collection of information has been estimated to average 40 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Form FDA-3500 (11/22) OMB statement: “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.” U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Page 6 of 6

A Sample Answer For the Assignment: HIM 2433 MDC Reporting Adverse Reaction Question

Title: HIM 2433 MDC Reporting Adverse Reaction Question

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