BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 8471388 · Received April 1, 2019

    Report

    Report Number
    2438477-2019-00016
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    January 18, 2019
    Report Date
    April 1, 2019
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    UDI-DI
    00822383247151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A SHOWER CHAIR. THE END-USER DISCARDED THE CHAIR. THERE ARE NO PICTURES OF THE DEVICE. (B)(4) WILL BE UNABLE TO EVALUATE THE DEVICE. THE DEVICE WAS PURCHASED 3 MONTHS BEFORE IT BROKE. IT REQUIRED ASSEMBLY. IT WAS ADJUSTABLE FOR HEIGHT AND HAD GRIPS FOR THE FLOOR. END-USER CLAIMED THAT THE SHOWER CHAIR BROKE IN HALF FROM SIDE TO SIDE AND SHATTERED. THE BROKEN PLASTIC INJURED HIS HIP. THE END-USER WENT TO HIS THERAPIST AFTER THE INCIDENT. END-USER IS PARALYZED ON HIS LEFT SIDE SDE DUE TO A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262278 DRIVE BATH BENCH ILS UNKNOWN RTL12505 00822383247151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention