BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2399106 · Received January 5, 2012

    Report

    Report Number
    3004493922-2012-00001
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    May 12, 2011
    Report Date
    January 5, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL (B)(4) DETERMINED THIS IS AN MDR. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41RSOLIDB, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THE USER MANUAL PART NUMBER 1143206 REV G (FEB-09) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. 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 CONSUMER IS A (B)(6) MALE, (B)(6). THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CHAIR ALLEGEDLY TOOK OFF BY ITSELF AND HIT A BYSTANDER AND THEN RAN INTO A WALL. THE BYSTANDER ALLEGEDLY SUSTAINED A BROKEN FEMUR. THE CONSUMER ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES TO HIS HAND AND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41RSOLIDB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 Other