BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHEELCHAIR ACCESSORY

    MDR report key: 2409742 · Received January 11, 2012

    Report

    Report Number
    9616091-2012-00006
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 26, 2011
    Report Date
    January 10, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL R113 SERIAL NUMBER/DATE CODE IS UNKNOWN. THE USER MANUAL PART NUMBER 1023891 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). THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGEDLY, WHILE LIFTING THE RESIDENT, THE SLING RIPPED AND SHE FELL TO THE GROUND. UNKNOWN MODEL LIFT AND SOLID SLING (BLUE) WITH GREEN BAND (LARGE) WITHOUT COMMODE OPENING THE MODEL INFORMATION ON THE TAG IS ALLEGEDLY WASHED OUT.SERIOUS INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR ACCESSORY 890.3910 IOR INVAMEX R113

    Patients

    Seq Age Sex Outcome Treatment
    1 58 Other