BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 8682236 · Received June 10, 2019

    Report

    Report Number
    2438477-2019-00020
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    February 12, 2019
    Report Date
    April 15, 2019
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BATH CHAIR. THE DEVICE WAS RETRIEVED BY THE SERVICE PROVIDER. SERVICE PROVIDER DROPPED OFF THE CHAIR TO THE END-USER. THE NEXT DAY THE END-USER SAT ALONE ON THE CHAIR FOR 5 MINUTES. THE CHAIR BROKE CAUSING HIM TO FALL. HE HURT HIS BACK. PATIENT WAS INITIALLY HOSPITALIZED AFTER THE FALL. HE WAS TRANSFERRED TO A REHABILITATION CENTER WHERE HE WAS FOR 12 DAYS FOR PAIN AND MOBILITY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478262 DRIVE BATH SEAT ILS UNKNOWN 12022KD-4

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention