BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2682034 · Received August 4, 2012

    Report

    Report Number
    9615350-2012-00003
    Event Type
    Malfunction
    Date Received
    August 4, 2012
    Report Date
    August 2, 2012
    Manufacturer
    MOTION CONCEPTS
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL FT1920, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE CONSUMER IS A RESIDENT AT A FACILITY WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE FACILITY, (B)(6) NURSING HOME, CALLED STATING THAT THE GEL FROM A FLO-TECH CUSHION WAS ALLEGEDLY LEAKING OUT SLOWLY. A STAFF MEMBER AND A PATIENT ALLEGEDLY SLIPPED AND FELL FROM THE GEL. NO SERIOUS INJURY ALLEGED, JUST SORENESS.

    Description of Event or Problem · 1

    FACILITY STATED, "THE GEL FROM THE CUSHION WAS SLOWLY LEAKING OUT. A PATIENT AND STAFF MEMBER AT THE FACILITY SLIPPED AND FELL IN THIS PUDDLE OF GEL." CUSTOMER STATES BESIDES BEING SORE FROM THE FALL THERE ARE NO SERIOUS INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR MOTION CONCEPTS FT1920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other