BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 5963750 · Received September 20, 2016

    Report

    Report Number
    3005182235-2016-00032
    Event Type
    Injury
    Date Received
    September 20, 2016
    Date of Event
    August 29, 2016
    Report Date
    September 20, 2016
    Manufacturer
    N/A
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE END-USER WAS BURNED BY THE HEATING PAD (WITH USE OF A REPLACEMENT PAD). (B)(4) WAS NOTIFIED BY ONE OF OUR DISTRIBUTORS THAT THIS END-USER STATED SHE WAS BURNED WITH THE REPLACEMENT PAD USING THE HEATING PAD DEVICE. SHE PURCHASED THE HEATING PAD WITH AC ADAPTER FROM ONE DISTRIBUTOR, THEN PURCHASED A REPLACEMENT PAD FROM A SECOND DISTRIBUTOR. SHE CONTACTED THE SECOND DISTRIBUTOR ((B)(6) 2016), AND ADVISED THEM THAT SHE HAD BEEN BURNED WHILE USING THE REPLACEMENT PAD. (B)(4) CONTACTED THE END-USER AND FOUND SHE IS A (B)(6)-YEAR-OLD WOMAN. THE EVENT OCCURRED AT HER HOME WHILE SHE WAS IN CONTROL OF OPERATING THE DEVICE. SHE STATED SHE DID NOT FEEL ANY PAIN OR BURNING WHILE SHE WAS USING THE HEATING PAD, BUT NOTED SHE IS ON "A LOT OF NARCOTICS." SHE STATED SHE HAD RECEIVED THE BURNS 4 DAYS PRIOR, WHICH WOULD HAVE BEEN ON MONDAY, (B)(6)- (B)(4) WAS NOTIFIED ON (B)(4) 2016, AND SPOKE TO THE END-USER ON THAT SAME DAY. BY THIS TIME, THE BURNS HAD "POPPED AND ARE CRUSTED OVER," WITH THE EXCEPTION OF ONE, WHICH "STILL HAS FLUID IN IT AND IS READY TO BURST." SHE DID NOT SEEK MEDICAL ATTENTION FOR THE BURN. SHE STATED SHE HAD ONLY APPLIED (B)(6). SHE WAS SURPRISED BY ALL THE ATTENTION THIS HAD CAUSED, AND STATED SHE HAD FIGURED OUT WHAT HAD HAPPENED AND THAT IT WAS ALL HER FAULT. SHE PLUGGED THE HEATING PAD INTO A FOREIGN AC ADAPTER, AND SHE BELIEVES THAT IS WHY SHE WAS BURNED. SHE WAS VERY EMBARRASSED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO COMPASS HEALTH BRANDS ON (B)(6) 2016, AND INSPECTED ACCORDINGLY. UPON INSPECTION, THE ITEMS WERE FOUND TO HAVE BEEN USED WITH NORMAL WEAR. THE CUSTOMER STATED THAT SHE PLUGGED THE HEATING PAD INTO A FOREIGN AC ADAPTER, AND SHE BELIEVES THAT IS WHY SHE WAS BURNED. ONE OF THE UNITS RETURNED MAY BE THE REPLACEMENT, BECAUSE IT APPEARS TO HAVE BEEN UNUSED. THE OTHER UNIT'S STICKY PAD APPEARS TO BE DISCOLORED AND CRINKLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614978 N/A N/A IRT N/A N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other