BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACARE HEATWRAP - ADVANCED NECK PAIN THERAPY

    MDR report key: 10619279 · Received October 1, 2020

    Report

    Report Number
    MW5097013
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 29, 2020
    Manufacturer
    PFIZER / PF CONSUMER HEALTHCARE 1 LLC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATCH WAS USED AND CAUSED A SEVERE ALLERGIC REACTION (SWELLING) IN THE WHOLE BODY FOR SEVERAL DAYS. THE PRODUCT DIDN'T LABEL OR SPECIFY THE ACTIVE INGREDIENTS. ALLERGIC TO ASPIRIN. THERAPY DURATION: 1 HOUR. DIAGNOSE FOR USE: NECK PAIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075717 THERMACARE HEATWRAP - ADVANCED NECK PAIN THERAPY PACK, HOT OR COLD, DISPOSABLE IMD PFIZER / PF CONSUMER HEALTHCARE 1 LLC (L) EC2269

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other