BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 2794894 · Received October 4, 2012

    Report

    Report Number
    2438477-2012-00022
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    December 31, 2011
    Report Date
    September 4, 2012
    Manufacturer
    UNK
    Product Code
    NXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4) HAS RECEIVED UPDATED INFORMATION FROM AN ATTORNEY ON THE PATIENT INJURY FROM A PREVIOUS COMPLAINT INVOLVING A ROLLATOR ALLEGEDLY DISTRIBUTED BY (B)(4). IT IS ALLEGED THAT THE CLAIMANT WAS SITTING ON THE ROLLATOR WHEN THE RIGHT FRONT WHEEL BROKE OFF CAUSING HER TO FALL AND BREAK HER LEFT HUMERUS. (B)(4) HAD REACHED OUT TO THE CLAIMANT¿S ATTORNEY TO HAVE THE ALLEGED PRODUCT RETURNED FOR EVALUATION. BUT OUR REQUEST WAS REFUSED. ATTORNEY DID SEND PHOTOS AND MEDICAL RECORDS. IT IS REPORTED THAT THE PATIENT WAS ADMITTED TO A REHAB UNIT FOR FIVE (5) DAYS AND DISCHARGED IN STABLE CONDITION. THIS MDR REPORT IS BASED ON THE COMPLAINT FROM CLAIMANT¿S ATTORNEY AND RELATING MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR NXE UNK R728RD OR R8RD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention