BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3241879 · Received July 22, 2013

    Report

    Report Number
    9616091-2013-01273
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 3, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CORPORATE COMMUNICATIONS RECEIVED VOICEMAIL FROM (B)(6) (END USER'S HUSBAND) STATING END USER JUST ARRIVED HOME FROM KNEE SURGERY. THEY WERE DELIVERED AN IVC WHEELCHAIR DUE TO THE SURGERY AND IT FAILED AFTER FIVE HOURS OF USE. THE PIVOT/C-CLAMP FOR THE UP AND DOWN MOVEMENT OF THE LEG REST FELL OFF AND HER LEG FELL DOWN; HOPES THERE WAS NO ADDITIONAL DAMAGE TO KNEE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341344 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T42RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other