BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 63324 · Received January 8, 1997

    Report

    Report Number
    2210968-1997-00001
    Event Type
    Malfunction
    Date Received
    January 8, 1997
    Report Date
    November 19, 1996
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE. DURING ANASTOMOSIS, CUSTOMER REPORTED PRODUCT SNAPPED/SPLIT. NOTE: OUTCOME TO PT DIES 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 PROLENE POLYPROPYLENE SUTURE Implant NON-ABSORBABLE SUTURE GAW ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO