BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM ENURESIS ALARM

    MDR report key: 7984251 · Received October 18, 2018

    Report

    Report Number
    MW5080685
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    October 15, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MALEM MEDICAL LTD.
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CHILD WAS BROUGHT INTO THE URGENT CARE DEPT FOR NECK BURNS. THE CHILD WAS USING AN ENURESIS ALARM AT NIGHT WHEN IT MALFUNCTIONED AND OVERHEATED. THE MALFUNCTION CAUSED THE ALARM TO GET VERY HOT AND BURN THE CHILD AT THE POINT OF CONTACT ON HIS NECK. PARENTS REPORTED THAT THE ALARM HAS ALSO CHANGED SHAPE (PLASTIC PART) FROM THE EXCESS HEAT THAT WAS DISSIPATED BY THE ALARM. BATTERIES LEAKED OUT AS A RESULT OF THE OVERHEATING. THE CHILD WAS BRUISED AND TREATED BY THE ATTENDING NURSE AND LATER DISCHARGED. THERE ARE F/U VISITS TO SEE HOW THE CHILD IS DOING. PARENTS HAVE BEEN TOLD TO DISCONTINUE USING THE ENURESIS ALARM AND REPORT THE INCIDENT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817298 MALEM ENURESIS ALARM ALARM, CONDITIONED RESPONSE ENURESIS KPN MALEM MEDICAL LTD. M05S

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention