BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASENSE

    MDR report key: 5416109 · Received January 27, 2016

    Report

    Report Number
    8022077-2016-00010
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 26, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SITTING ON THE BATH SEAT WHILE TAKING A SHOWER AND FELL. SHE CLAIMS THAT THE MIDDLE SCREW IS STRIPPED. SHE HAS BRUISES ON HER BACK AND BOTTOM. WE SENT HER A REPLACEMENT UNIT AND SHE WILL SEND US THE DEFECTIVE UNIT HERE FOR INVESTIGATION. WE WILL SEND A FOLLOW-UP REPORT INCLUDING THE DEVICE EVALUATION ONCE WE RECEIVE THE UNIT HERE AND THE INVESTIGATION IS DONE.

    Description of Event or Problem · 1

    CUSTOMER WAS SITTING ON THE BATH SEAT WHILE TAKING A SHOWER AND FELL. SHE CLAIMS THAT THE MIDDLE SCREW IS STRIPPED. SHE HAS BRUISES ON HER BACK AND BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53992 AQUASENSE AQUASENSE ADJUSTABLE BATH SEAT ILS AMG MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other