BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C350 CORPUS

    MDR report key: 2530269 · Received March 30, 2012

    Report

    Report Number
    1221084-2012-00007
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    August 15, 2010
    Report Date
    March 29, 2012
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K071650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: MFR INSPECTED THE WHEELCHAIR IN SEPT 2010. MFR OBSERVED DURING THE INSPECTION THAT THE LEFT FRONT TIRE WAS DETACHED FROM THE WHEEL/RIM, BUT THERE WAS NO DAMAGE TO THE WHEEL/RIM. THE TIRE DID NOT HAVE ANY VISIBLE DAMAGE. MFR CONCLUDED THAT TIRE CAME OFF OF THE WHEEL/RIM AS A RESULT OF IMPROPER USE OF THE WHEELCHAIR. THE WHEELCHAIR OPERATED PROPERLY WHEN INSPECTED.

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE LEFT CASTER TIRE CAME OFF OF THE RIM WHEN THE USER WAS ENTERING A STORE, AND USER FELL FROM THE WHEELCHAIR SUFFERING MINOR INJURIES. MFR INSPECTED THE WHEELCHAIR WITH THE DEALER. THE WHEEL/RIM WAS NOT DAMAGED AND THE SOLID TIRE HAD NO DAMAGE. IT APPEARS THAT THE TIRE CAME OFF OF THE RIM AS A RESULT OF THE MANNER OF USE OF THE WHEELCHAIR. THE CASTER COULD HAVE COME IN CONTACT WITH A CURB WHILE PERPENDICULAR TO THE CURB AND IF THE USER MOVES THE CHAIR FORWARD, THE TIRE CAN ROLL OFF THE RIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C350 CORPUS POWER WHEELCHAIR ITI PERMOBIL AB

    Patients

    Seq Age Sex Outcome Treatment
    1