BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2760173 · Received September 26, 2012

    Report

    Report Number
    9616091-2012-00385
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    February 1, 2002
    Report Date
    September 25, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDLX, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 12 YEARS 2 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1065497, WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE MALE CONSUMER'S AGE IS (B)(6). THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER ALLEGES THAT THE CROSS BRACES ON HIS TDLX MANUAL WHEELCHAIR BROKE. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 Other