BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2841041 · Received November 20, 2012

    Report

    Report Number
    1525712-2012-02242
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 17, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MODEL XTRA SERIAL NUMBER/DATE CODE (B)(4) IS LESS THAN A MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1026793, REV.D, (SEP-04) 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 CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. 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.THE MALFUNCTION HAS NOT BEEN CONFIRMED. SINCE INVACARE HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT IF ANY FURTHER NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. THE EXTENT OF INJURY IS UNKNOWN THEREFORE THIS INCIDENT IS BEING FILED AS A SERIOUS INJURY. OF NOTE: THIS IS A NEW DEVICE, JUST DELIVERED TO THIS END USER. REPORTEDLY THE END USER ALTERED THE DEVICE BY CUTTING OFF THE FOAM GRIPS, THEREFORE THE INCIDENT IS LIKELY NOT THE FAULT OF THIS DEVICE.

    Description of Event or Problem · 1

    DEALER STATES USER COULD NOT GRIP THE ARMS WHILE TRANSFERRING AND USER CUT OFF FOAM GRIPS. THE END USER IS NOW COMPLAINING OF CUTTING THEIR HANDS AT THE END OF THE TUBE OF THE ARM. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION HOWEVER TO DATE, NO FURTHER INFORMATION OR EXTENT OF INJURY IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET XTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other