BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 6150912 · Received December 5, 2016

    Report

    Report Number
    MW5066569
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    December 4, 2016
    Report Date
    December 5, 2016
    Manufacturer
    MALEM
    Product Code
    KPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I BOUGHT THE MALEM BEDWETTING ALARM FROM THE BEDWETTING STORE. (B)(6). AT NIGHT MY SON YELLED LOUDLY AND I RAN TO HIS ROOM. WE NOTICED THAT THE MALEM ALARM WAS SCORCHING HOT AND IT HAD CREATED A BURN MARK ON MY SON'S NECK. IT WAS SIMILAR TO A HOT IRON. I REMOVED THE ALARM AND THREW IT ON THE BED, LATER PLACED THE ALARM IN AN OVEN MITT TILL IT COOLED DOWN AS I DIDN'T WANT TO BURN MY BED SHEET. APPLIED A BURN OINTMENT ON MY SON'S NECK. I THINK IT WILL TAKE SEVERAL WEEKS OR EVEN MONTHS FOR THE BURN MARK TO HEAL. THESE KIND OF CHEAP PRODUCTS SHOULD BE REMOVED PERMANENTLY. PLEASE TAKE STRICTEST ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795814 MALEM BEDWETTING ALARM MALEM BEDWETTING ALARM KPN MALEM NONE ON PRODUCT BOX NONE ON PRODUCT BOX

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other OTC MEDS: NONE.| RX MEDS: NONE.