BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK KNIFE

    MDR report key: 11789864 · Received May 7, 2021

    Report

    Report Number
    11789864
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 19, 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

    TIP OF VEIN HOOK BROKE OFF DURING PROCEDURE. WE WERE UNABLE TO LOCATE THE TIP, X-RAY TAKEN, AND SHOWED THE TIP IN LATERAL ASPECT OF THE RIGHT LOWER THIGH. DOCTOR MADE AWARE HE DID NOT FEEL THAT HE COULD SUCCESSFULLY RETRIEVE THE TIP DUE TO SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686477 HOOK KNIFE HOOK, SURGICAL, GENERAL & PLASTIC SURGERY GDG CAROLON CO. 48226-01

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA