BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2307545 · Received October 26, 2011

    Report

    Report Number
    9616091-2011-00030
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 25, 2011
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX28RF, SERIAL NUMBER/DATE CODE (B)(4)IS APPROXIMATELY 4 MONTHS OLD. THE USER MANUAL PART NUMBER 1110546 REV G (FEB-11) WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    FRONT CASTER ON WHEELCHAIR ALLEGEDLY CRACKED PER CONSUMER. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other