BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE*POLYPROLENE SUTURE

    MDR report key: 76612 · Received March 14, 1997

    Report

    Report Number
    2210968-1997-00053
    Event Type
    Malfunction
    Date Received
    March 14, 1997
    Date of Event
    February 12, 1997
    Report Date
    February 13, 1997
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE. CUSTOMER REPORTS THAT SUTURE BROKE DURING CORONARY ARTERY BYPASS SURGERY WITH NO ALLEGED 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 FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE*POLYPROLENE SUTURE Implant NON-ABSORBABLE SUTURE GAW ETHICON INC. N/A JHE842

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO