BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLPATCH WARMING PAIN RELIEF PATCH

    MDR report key: 3815642 · Received May 6, 2014

    Report

    Report Number
    1320681-2014-00005
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THE MENTHOLATUM COMPANY
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER IS AN ELDERLY WOMAN WHO CLAIMS TO HAVE USED WELLPATCH WARMING PAIN RELIEF PATCH ON HER LOWER BACK/HIP AREA. UPON REMOVAL, SOME SKIN HAD BEEN REMOVED AND THE AREA WAS RED. SHE WAS HOSPITALIZED FOR PNEUMONIA AND WAS CONCOMITANTLY TREATED FOR THE BURN WITH MUPIROCIN 2 PERCENT INTENT FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270126 WELLPATCH WARMING PAIN RELIEF PATCH PACK, HOT OR COLD, DISPSOABLE IMD THE MENTHOLATUM COMPANY NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other