BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 166072 · Received May 5, 1998

    Report

    Report Number
    2210968-1998-00162
    Event Type
    Malfunction
    Date Received
    May 5, 1998
    Report Date
    April 8, 1998
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLE PULL OFF: INTERNATIONAL AFFILIATE REPORTS THAT NEEDLE PREMATURELY RELEASED FROM SUTURE DURING ENT PROCEDURE. THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PT RELATED TO THIS EVENT. NOTE: OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATION OF 07/31/96 REQUIRES REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR. ETHICON INC'S INTERNAL CONTROL NUMBER IS: 9830287-00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE Implant ABSORBABLE SUTURE GAL ETHICON INC. NA KGR645

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO