BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 162972 · Received April 15, 1998

    Report

    Report Number
    2210968-1998-00119
    Event Type
    Malfunction
    Date Received
    April 15, 1998
    Report Date
    March 17, 1998
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE BREAKAGE POST OP: INTERNATIONAL AFFILIATE REPORTS THAT SUTURE BROKE 3 WEEKS FOLLOWING KNEE SURGERY. THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT RELATED TO THIS EVENT. NOTE: OUTCOME TO PATIENT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATION OF 07/31/96 REQUIRES REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR.

    Description of Event or Problem · 1

    ETHICON INC'S INTERNAL CONTROL NUMBER IS: 9830195-00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE Implant ABSORBABLE SUTURE GAM ETHICON, INC. NA KH7649

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO