BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLPATCH WARMING PAIN RELIEF PATCH

    MDR report key: 3683480 · Received March 3, 2014

    Report

    Report Number
    1320681-2014-00002
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 3, 2014
    Manufacturer
    THE MENTHOLATUM COMPANY
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER PLACED WELLPATCH AIR-ACTIVATED HEAT WARMING PATCH ON LOWER ABDOMEN TO RELIEVE CRAMPS. SHE REMOVED THE PATCH AFTER APPROX 2 HOURS BECAUSE THE PATCH FELT VERY WARM. UPON REMOVAL, SOME SKIN WAS REMOVED AND THE AREA WAS BLISTERED. TWO DAYS LATER, SHE SOUGHT MEDICAL ATTENTION AT AN ER AND WAS PRESCRIBED CEPHALEXIN FOR INFECTION. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128411 WELLPATCH WARMING PAIN RELIEF PATCH PACK, HOT OR COLD, DISPOSABLE IMD THE MENTHOLATUM COMPANY 1310B5

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other IBUPROFEN FOR CRAMPS