BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1980775 · Received February 1, 2011

    Report

    Report Number
    2438477-2011-00002
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2008
    Report Date
    January 3, 2011
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS REC'D AN ATTORNEY LETTER ALLEGING THAT THE CLAIMANT WAS INJURED FROM ONE OF THE ROLLATORS ORIGINALLY DISTRIBUTED BY DRIVE MEDICAL. IT WAS ALLEGED THAT THE ROLLATOR'S FRONT-RIGHT CASTER BROKE CAUSING THE CLAIMANT TO FALL AND ALLEGEDLY SUSTAIN A RIGHT TRICEP TENDON RUPTURE REQUIRING SURGERY AND LOSING MOBILITY AND STRENGTH IN HIS RIGHT ARM AND HAND. BECAUSE THE SERIAL NUMBER OF THE ALLEGED DEVICE WAS REPORTED IN A FORMAT THAT IS NOT BEING USED BY DRIVE MEDICAL, WE ARE NOT ABLE TO IDENTIFY THE MFR. IN ADDITION, THIS MODEL OF ROLLATOR HAS BEEN DISCONTINUED FROM THE US MARKET SINCE NOVEMBER OF 2008. THIS MDR REPORT IS BASED ON THE ATTORNEY LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR ITJ UNKNOWN 540 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention