BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 76984 · Received March 18, 1997

    Report

    Report Number
    2210968-1997-00061
    Event Type
    Malfunction
    Date Received
    March 18, 1997
    Report Date
    February 20, 1997
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUTURE BROKE DURING SURGERY FOR BOWEL RESECTION. CUSTOMER STATES THAT THERE ARE NO ALLEGED CONSEQUENCED TO THE PT. 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-ABOSORBABLE SUTURE GAW ETHICON, INC. NA JHE252

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO