BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK KNIFE

    MDR report key: 11831236 · Received May 17, 2021

    Report

    Report Number
    11831236
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 23, 2021
    Report Date
    April 26, 2021
    Manufacturer
    CAROLON CO.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING THE HOOK KNIFE FROM THE BODY, THE TIP BROKE OFF. IT WAS NOT IN THE PATIENT AT THE TIME OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734063 HOOK KNIFE HOOK, SURGICAL, GENERAL & PLASTIC SURGERY GDG CAROLON CO. 48226-01

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA