BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 68157 · Received February 6, 1997

    Report

    Report Number
    2210968-1997-00018
    Event Type
    Malfunction
    Date Received
    February 6, 1997
    Date of Event
    January 8, 1997
    Report Date
    January 14, 1997
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE. CUSTOMER REPORTS THAT SUTURE SNAPPED SEVERAL TIMES DURING CORONARY ARTERY BYPASS GRAFT SURGERY WITH NO ADVERSE CONSEQUENCE 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 PROLENE POLYPROPYLENE SUTURE Implant NON-ABSORBABLE SUTURE GAW ETHICON INC. NA JAE024

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO