BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2030144 · Received March 15, 2011

    Report

    Report Number
    1525712-2011-00094
    Event Type
    Other
    Date Received
    March 15, 2011
    Date of Event
    December 26, 2008
    Report Date
    March 11, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER ALLEGED STATED, THEY PICKED UP THE CHARGER AND BURNT THEIR HAND. MANUFACTURE SPOKE WITH DEALER WHO SERVICED THE CONSUMER'S CHAIR AFTER, THE ALLEGED EVENT OCCURRED. THE DEALER REPORTED THAT THE CONSUMER HAD TOLD THEM THEIR HAND JUST GOT HOT. NO BURN WAS OBSERVED ON THE CONSUMER'S HAND BY THE DEALER, AS THEY SPOKE WITH THE CONSUMER WHILE SERVICING THE CHAIR. THE CHARGER WAS REPLACED AND THE DEALER DID NOT RETURN THE CHARGER. CHAIR HAS REMAINED IN USE.

    Description of Event or Problem · 1

    THE CONSUMER STATED, THEY PLUGGED THE CHARGER INTO CHARGE THE BATTERIES. SHE LEFT THE CHARGER OVERNIGHT AND WHEN SHE PICKED IT UP THE NEXT DAY, IT ALLEGEDLY BURNED HER HAND. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR