BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 75520 · Received March 11, 1997

    Report

    Report Number
    2210968-1997-00066
    Event Type
    Malfunction
    Date Received
    March 11, 1997
    Report Date
    January 31, 1997
    Manufacturer
    ETHICON INC
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE. CUSTOMER REPORTS SUTURE BREAKAGE DURING SURGERY. THERE ARE NO ALLEGED CONSEQUENCES TO THE PATIENT ATTRIBUTED TO THIS EVENT. NOTE: OUTCOME TO PATIENT 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 HLPV05

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO