BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4211160 · Received October 29, 2014

    Report

    Report Number
    9616091-2014-02248
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 6, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER'S SON STATES THAT THE RECLINE CABLES ON BOTH SIDES OF THE CHAIR HAVE BROKEN. THE USER OF THE CHAIR HAS FUSED HIPS AND HAS TO BE LIFTED BY A LIFT INTO THE CHAIR. THE AIDES THEN ADJUST THE BACK WITH HER IN THE CHAIR UNTIL IT IS COMFORTABLE FOR HER. THE SON ALSO MENTIONED THAT ONE OF THE AIDES MENTIONED HAVING HURT HER SHOULDER TRYING TO LIFT THE CONSUMER INTO THE CHAIR BY HERSELF. THE CONSUMER DIDN'T HAVE THE SERIAL NUMBER AT TIME OF CALL. THE SON ALSO MENTIONED THAT THE LEFT ARM HITS THE LEFT WHEEL. THE ARM BASE SHOWS WEAR WHERE THE WHEEL HAS BEEN RUBBING. HE ALSO SAID THAT ONE OF THE LATCHES ON THE FRONT RIGGING WON'T LOCK IN PLACE EASILY. ONCE IT IS LATCHED, IT DOES STAY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692276 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other