BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ULTIMATE BEDWETTING ALARM

    MDR report key: 7960239 · Received October 11, 2018

    Report

    Report Number
    MW5080511
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 10, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING WRITTEN ON THE ADVICE OF THE CLINIC MY SON WAS ADMITTED TO LAST NIGHT. THIS ENURESIS ALARM PRODUCED A LARGE AMOUNT OF HEAT AND BURNT HIM. WE WERE LATE TO REMOVE THE ALARM AND IT SCARRED HIS SKIN. IT IS RATHER UNFORTUNATE THAT THE ALARM DID THAT. THE ALARM HAS ONLY BEEN USED FOR ONE NIGHT. THE TWO BATTERIES THAT ARE HOUSED IN THE ALARM ALSO LEAKED OUT FROM THE ALARM LIKE THEY SHORT CIRCUITED. THE ALARM PLASTIC HAS BENT FROM HEAT INWARDS LIKE THE PLASTIC NEARLY MELTED AND FUSED ON MY SON'S SKIN. WE ARE AFRAID OF USING THE ALARM AND HAVE LEFT IT WITH THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799384 MALEM ULTIMATE BEDWETTING ALARM ALARM, CONDITIONED RESPONSE ENURESIS - ALARM KPN MALEM MEDICAL LTD. M04SB

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR