BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 642037 · Received October 19, 2005

    Report

    Report Number
    2210968-2005-00626
    Event Type
    Injury
    Date Received
    October 19, 2005
    Date of Event
    October 1, 1994
    Report Date
    October 3, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY AND WEDGE RESECTION OF RIGHT OVARY IN 08/1994 FOR FIBROIDS AND PERSISTENT UTERINE BLEEDING. THE PATIENT HAD A LOW-GRADE FEVER FOLLOWING THE SURGERY (99.3F), AND A FEVER OF 100.8F ON 08/15/1994. SHE WAS DISCHARGED ON ANTIBIOTICS (CIPROFLOVACIN) ON 08/17/1994, THE WOUND WAS HEALING. EIGHT WEEKS LATER, THE PATIENT WAS DIAGNOSED WITH A VESICOVAGINAL FISTULA, WHICH CAUSED HER URINARY SPASMS, INCONTINENCE AND PAIN. SHE UNDERWENT A TRANSVAGINAL REPAIR SURGERY IN 11/1994. SHE HAS CONTINUED TO HAVE COMPLICATIONS, AND HAS HAD MULTIPLE CYCTOSCOPIES, TRANSVAGINAL REPAIR OF THE FISTULA IN 11/1994 AND ON 06/1995, EXPLORATORY, EXCISION OF VESICOVAGINAL FISTULA, RIGHT OOPHORECTOMY AND CYSTOMY ON 09/1996; UROSTOMY, ILEAL LOOP DIVORSION IN 4/1997, TOTAL CYSTOTOMY IN 03/1999, AND MULTIPLE PROCEDURES FOR PAIN CONTROL.

    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 38 YR Required Intervention