BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1980686 · Received January 28, 2011

    Report

    Report Number
    2438477-2011-00001
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    July 12, 2009
    Report Date
    December 28, 2010
    Manufacturer
    SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS REC'D AN ATTORNEY LETTER ALLEGING THAT THE CLAIMANT WAS INJURED FROM ONE OF ROLLATORS ORIGINALLY DISTRIBUTED BY DRIVE MEDICAL. IT WAS ALLEGED THAT THE ROLLATOR FRONT-LEFT BAR CRACKED CAUSING THE CLAIMANT TO FALL AND SUSTAIN INJURIES. DETAIL OF THE INJURIES IS UNK. DRIVE MEDICAL HAS SUBSEQUENTLY REC'D EIGHT (8) PHOTOS ON THE ALLEGED DEVICE. WE HAVE NOTIFIED THE DEVICE MFR AS SOON AS WE WERE AWARE OF THE EVENT AND REQUIRED THE MFR TO CONDUCT AN INTERNAL INVESTIGATION. THIS MDR REPORT IS BASED ON THE INITIAL COMPLAINT AND MFR'S FEEDBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR INM SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO. 726BL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization