BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLPATCH

    MDR report key: 5410606 · Received February 4, 2016

    Report

    Report Number
    1320681-2016-00014
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    December 29, 2015
    Report Date
    February 4, 2016
    Manufacturer
    THE MENTHOLATUM COMPANY
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER SOUGHT MEDICAL ATTENTION FOR A SECOND DEGREE BURN ON FOREARM FROM DISPOSABLE HEAT PATCH. SHE INDICATED THAT SHE HAD APPLIED IT BEFORE BED AND WOKE UP WITH THE WOUND UPON REMOVAL OF THE PATCH. NO BURN DEBRIDEMENT INDICATED. DRESSING WAS APPLIED TO THE BURN AREA WITH SILVADENE CREAM AND STERILE NON-ADHERING GAUZE. SHE WAS INSTRUCTED TO CONTINUE TO APPLY 1% SILVADENE CREAM 2 TIMES DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70238 WELLPATCH PACK , HOT OR COLD, DISPOSABLE IMD THE MENTHOLATUM COMPANY 1406C6

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other