BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 533888 · Received July 13, 2004

    Report

    Report Number
    2210968-2004-00385
    Event Type
    Injury
    Date Received
    July 13, 2004
    Date of Event
    August 14, 1997
    Report Date
    June 16, 2004
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED FOR ELECTIVE TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHRECTOMY AND DISCHARGED IN STABLE CONDITION 3 DAYS LATER. POST-OPERATIVELY THE PT WAS SEEN IN THE CLINIC SIX DAYS LATER WITH A DIAGNOSIS OF "WOUND INFECTION." CIPRO WAS PRESCRIBED. IN 08/1997, 09/1997 AND 09/1997 PT WAS SEEN FOR FOLLOW UP. IN 09/1997 IT WAS NOTED THAT THE INCISION WAS HEALING, NO PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention