BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM

    MDR report key: 8164784 · Received December 13, 2018

    Report

    Report Number
    MW5082140
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 12, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER HAS SUFFERED FROM SKIN BURNS WHEN SHE WAS USING HER MALEM BEDWETTING ALARM. IT HAS BEEN HAPPENING FOR A FEW DAYS AND I HAVE NOTICED A SMALL RED PATCH OF HER NECK AT NIGHT WHEN SHE USES THE ALARM. AT FIRST I THOUGHT IT WAS JUST RASH, BUT NOW AFTER A WEEK, I REALIZED THAT IT WAS ACTUALLY THE HEAT FROM THE PLASTIC THAT HAS SCARRED MY DAUGHTER'S SKIN. IT IS ONLY GETTING WORSE, AND PINKISH SCARS ARE GROWING. DISCONTINUED USING THE ALARM AND WILL RETURN TO THE MFR. IT'S GETTING HOT EVERY TIME IT'S USED. DEFECTIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998310 MALEM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M05

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other