BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 7654750 · Received July 2, 2018

    Report

    Report Number
    2438477-2018-00033
    Event Type
    Injury
    Date Received
    July 2, 2018
    Report Date
    July 2, 2018
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. DRIVE'S PMS ASSOCIATE HAS BEEN UNABLE TO ACQUIRE PERSONAL DATA FOR THE END-USER. THE SERVICE PROVIDER IS UNSURE OF THE EXACT MODEL NUMBER AND HAS PROVIDED BEST GUESS. THE SERVICE PROVIDER HAS INFORMED US THAT THE DEVICE HAS BEEN DISCARDED AND IS UNAVAILABLE FOR EVALUATION. THE FRAME WELDINGS ON BOTH FRONT LEGS REPORTEDLY SNAPPED. THE END-USER WAS TAKEN TO THE HOSPITAL WITH A BROKEN HIP. NO INFORMATION IS AVAILABLE REGARDING CIRCUMSTANCES AND OUTCOMES OF THE INCIDENT. NO MEDICAL HISTORY OR TREATMENT IS KNOWN. WE WILL INFORM ALL MANUFACTURERS OF THIS DEVICE OF THE INCIDENT AND GATHER DATA FROM ALL OF THEM IN AN OVER ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499021 DRIVE ROLLATOR ITJ UNKNOWN R726BL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R