BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNIHOOK

    MDR report key: 12924878 · Received December 2, 2021

    Report

    Report Number
    MW5105757
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    October 29, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BRIGGS MEDICAL SERVICE COMPANY / DMS HOLDINGS, INC.
    Product Code
    HGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AMNIHOOK CAME PACKAGED WITH A HAIR SEAL THROUGHOUT THE PACKAGE. CAUGHT BY OBT WHEN CS COULD NOT FIND WHERE THEY BELONGED. OBT OPENED BOX TO SEE WHAT WAS INSIDE TO INSTRUCT ON STORAGE LOCATION AND SPOTTED HAIR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817419 AMNIHOOK AMNIHOOK AMNIOTIC MEMBRAN PERFORATO HGE BRIGGS MEDICAL SERVICE COMPANY / DMS HOLDINGS, INC. OB01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown