BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER ADJUSTABLE RING

    MDR report key: 208660 · Received February 4, 1999

    Report

    Report Number
    1035798-1998-00005
    Event Type
    Malfunction
    Date Received
    February 4, 1999
    Report Date
    October 22, 1998
    Manufacturer
    BREMER MEDICAL, INC.
    Product Code
    HAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING APPLICATION OF HALO TRACTION BAIL, A THREADED HOLE IN THE BACK SECTION OF ADJUSTABLE RING BECAME STRIPPED. THE HOLE WAS THE ONE USED BY THE BAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER ADJUSTABLE RING ORTHOTIC BRACE HAX BREMER MEDICAL, INC. NA 28092

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN