BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2307100 · Received October 25, 2011

    Report

    Report Number
    9616091-2011-00027
    Event Type
    Malfunction
    Date Received
    October 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    February 27, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW-UP #001 - INITIAL PR #(B)(4) ISSUED MFG REPORT #9616091-2011-00027. THE COMPONENT, SEAT UPHOLSTERY, PART NUMBER 8881091655, WAS RETURNED FOR EVALUATION. PRODUCT WAS APPROXIMATELY 3 MONTHS OLD AT THE TIME OF THE INCIDENT. THE HOLES WHERE THE SEAT ATTACHES WERE ELONGATED. THIS TYPICALLY OCCURS DUE TO A LOAD PLACED ON THE SEAT CAUSING THE HOLES TO ELONGATE. THE ADDITIONAL DAMAGE TO THE SEAT IS MOST LIKELY DUE TO USER ABUSE. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX2 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 11 MONTHS OLD. THE USER MANUAL PART NUMBER 1110546 REV F (AUG-10) 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.

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX2 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 11 MONTHS OLD. THE USER MANUAL PART NUMBER 1110546 REV F (AUG-10) 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

    CONSUMER ALLEGES THAT THE SEAT UPHOLSTERY HAS BEEN LOOSENING GRADUALLY FROM THE SIDE FRAMES. IT IS ALLEGEDLY ALMOST DETACHING AND CONSUMER IS AFRAID OF FALLING OUT OF THE CHAIR. CONSUMER ALLEGES THAT SHE IS WITHIN THE WEIGHT CAPACITY OF THE CHAIR. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    CONSUMER ALLEGES THAT THE SEAT UPHOLSTERY HAS BEEN LOOSENING GRADUALLY FROM THE SIDE FRAMES. IT IS ALLEGEDLY ALMOST DETACHING AND CONSUMER IS AFRAID OF FALLING OUT OF THE CHAIR. CONSUMER ALLEGES THAT SHE IS WITHIN THE WEIGHT CAPACITY OF THE CHAIR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 78 DA Other