BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL (POLLGLECAPRONE 25) SUTURE

    MDR report key: 100958 · Received June 26, 1997

    Report

    Report Number
    100958
    Event Type
    Malfunction
    Date Received
    June 26, 1997
    Date of Event
    March 22, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER MEDWATCH #301-594-3140-0002-97 STATES THAT DURING POST-PARTUM REPAIR OF A PERINEAL LACERATION, NEEDLE BROKE OFF FROM SUTURE AND BECAME EMBEDDED IN LABIAL, VAGINAL WALL. NEEDLE WAS RETRIEVED AND THERE ARE NO REPORTED CONSEQUENCES TO THE PT. NOTE: OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATION OF 7/31/96 REQUIRES REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLLGLECAPRONE 25) SUTURE Implant ABSORBABLE SUTURE GAM ETHICON, INC. NA HD9481

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO