BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR

    MDR report key: 22235 · Received June 6, 1995

    Report

    Report Number
    MW1006154
    Event Type
    Other
    Date Received
    June 6, 1995
    Date of Event
    May 9, 1995
    Report Date
    May 10, 1995
    Manufacturer
    WHITAKER GENERAL MEDICAL CORP.
    Product Code
    IOR
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MFR, INVACARE CORPORATION. INVACARE REQUESTED ST. CLAIR SEND THE CASTERS TO THEM & OFFERED TO REPLACES THE CASTERS AT NO COST TO ST. CLAIRE. HOWEVER, ST. CLAIRE DID NOT WANT REPLACEMENT CASTERS & DECLINED INVACARE'S REQUEST TO HAVE ST. CLAIRE RETURN THE PRODUCT FOR TESTING & EVALUATION. AT THIS TIME, INVACARE STATES THAT "BASED ON THE SERIAL NUMBER THE WHEELCHAIR WAS AT LEAST 10 TO 15 YRS OLD & WITHOUT DAMAGED CASTERS, THEY ARE UNABLE TO RESEARCH THE COMPLAINT & PROVIDE A SOLUTION." GENERAL MEDICAL IS NOT AWARE OF ANY OTHER INCIDENTS WITH THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR WHEELCHAIR IOR WHITAKER GENERAL MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other