BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 446808 · Received March 5, 2003

    Report

    Report Number
    2210968-2003-00088
    Event Type
    Malfunction
    Date Received
    March 5, 2003
    Date of Event
    February 3, 2003
    Report Date
    February 14, 2003
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    GAW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE FRAYED AND THEN BROKE DURING A CARDIOVASCULAR PROCEDURE. NHO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. SAN LORENZO NA RJE866

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN