BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON, INC

    MDR report key: 381476 · Received March 7, 2002

    Report

    Report Number
    MW1024320
    Event Type
    Injury
    Date Received
    March 7, 2002
    Date of Event
    May 8, 2001
    Report Date
    March 7, 2002
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    TO CLOSE INCISION SUBDURALLY FOLLOWING LAMINECTOMY AT L4/5, VICRYL POLYGLACTIN 910 SUTURES -#1- WAS USED. TWO WEEKS POST OPERATIVE PT DEVELOPED MASSIVE INFECTION. SURGEON ADVISED PT THAT SUTURES HAD BEEN CONTAMINATED AND HAD CAUSED INFECTION. SURGEON ADVISED THAT RECALLED VICRYL SUTURES HAD NOT BEEN REMOVED FROM SHELF POST 2/2001 RECALL ISSUED BY ETHICON. PT'S SED RATE IS LIFE THREATENINGLY HIGH. PLEASE ADVISE AS TO LAWSUITS PENDING ARISING FROM EHTICON 2/2001 RECALL. OSTEOMYELITIS AT L3 AND L4 WITH SUSPECT EPIDURAL ABSCESS. SUTURE FAILED TO HOLD HARDWARE; RE-OPERATED USING DIFFERENT SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON, INC COATED VYCRYL POLYGLACTIN 910 SUTURES GAM ETHICON, INC. COATED VICRYL QA8009

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening BACTERIA.| SUTURE WAS NOT STERILE AND CONTAMINATED WITH ECOLI| BACTERIA.| SUTURE WAS NOT STERILE AND CONTAMINATED WITH ECOLI