BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE *POLYPROPLYENE SUTURE

    MDR report key: 71909 · Received February 28, 1997

    Report

    Report Number
    2210968-1997-00041
    Event Type
    Malfunction
    Date Received
    February 28, 1997
    Report Date
    January 29, 1997
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE BROKE DURING SURGERY WITH NO ADVERSE CONSEQUENCE TO 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 *POLYPROPLYENE SUTURE Implant NON-ABSORABLE SUTURE GAW ETHICON INC. N/A JHE544

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO