BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALEM BEDWETTING ALARM

    MDR report key: 6145296 · Received December 4, 2016

    Report

    Report Number
    MW5066531
    Event Type
    Injury
    Date Received
    December 4, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 4, 2016
    Manufacturer
    MALEM MEDICAL
    Product Code
    KPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON WAS USING A BEDWETTING ALARM. IT EXPLODED AT NIGHT AND BURNT HIS NECK. IF IT WAS NOT FOR HIS T-SHIRT, HE COULD HAVE BEEN IN THE HOSPITAL WITH A HOLE IN HIS NECK. THE PRODUCT WAS OVERHEATED AND CAUGHT FIRE. AT NIGHT, I PUT THE SENSOR ON MY SON'S PAJAMA AND THE ALARM ON HIS T-SHIRT NEAR THE NECK. THIS IS THE FIRST TIME I WAS USING THIS PRODUCT. I SET IT UP AS PER THE INSTRUCTIONS, INSTALLED BATTERIES AND LET MY SON IN THE ROOM. WITHIN AN HOUR, I HEARD A LOUD SCREAM AND MY SON WAS CRYING LOUDLY. I RUSHED TO HIM AND NOTICED THAT THE BLUE MALEM BEDWETTING ALARM HAD PARTIALLY MELTED AND MY SON'S NECK WAS BURNED RED. THE ALARM HAS EXPLODED AND BURNT A HOLE IN HIS T-SHIRT. I IMMEDIATELY REMOVED THE ALARM AND THREW IT ON THE SIDE. I STILL HAVE IT IN MY POSSESSION. I PURCHASED THE MALEM BEDWETTING ALARM FROM (B)(6). I RUSHED MY SON TO THE ER AND THEY TOOK CARE OF HIM. I AM WORRIED THAT IF I HAD NOT CHECKED ON MY SON ON TIME, HE WOULD HAVE PERMANENT DAMAGE. THIS IS A DANGEROUS PRODUCT SOLD TO HELPLESS CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794650 MALEM BEDWETTING ALARM ENURESIS ALARM KPN MALEM MEDICAL M05

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R