BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7042386 · Received November 17, 2017

    Report

    Report Number
    2210968-2017-71308
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    February 11, 2014
    Report Date
    October 23, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: INT UROGYNECOL J 2014;25:993-996. DOI 10.1007/S00192-013-2304-7.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿ACTINOMYCES INFECTION APPEARING FIVE YEARS AFTER TROCAR-GUIDED TRANSVAGINAL MESH PROLAPSE REPAIR¿ THE PATIENT UNDERWENT ANTERIOR VAGINAL WALL REPAIR USING TROCAR-GUIDED TRANSOBTURATOR TRANSVAGINAL MESH REPAIR PROCEDURE FOR AND MESH WAS IMPLANTED. THE SURGICAL PROCEDURE WAS UNEVENTFUL. EIGHT MONTHS AFTER SURGERY, ASYMPTOMATIC MESH EXPOSURE WAS DIAGNOSED WITH UNSUCCESSFUL CONSERVATIVE THERAPY WITH ESTRIOL AND LOCAL ANTI-INFECTIVE TREATMENT, FOLLOWED BY RESECTION OF THE EXPOSED MESH IN (B)(6) 2006. PARTIAL REMOVAL OF THE PROTRUDED MESH WAS REPEATED IN (B)(6) 2007. FOUR YEARS AFTER THE SURGERY IN (B)(6) 2009, THERE WAS A RECURRENCE OF ASYMPTOMATIC MESH EXPOSURE. THE PATIENT WAS OFFERED MESH REMOVAL UNDER GENERAL ANESTHESIA BUT PREFERRED OUTPATIENT TRIMMING OF THE EXPOSED MESH AND CONSERVATIVE TREATMENT WITH LOCAL ESTRIOL. IN (B)(6) 2010, THE PATIENT PRESENTED WITH INCREASING LOWER ABDOMINAL PAIN AND VAGINAL BLEEDING, WHICH HAD BEEN INCREASING OVER THE PREVIOUS 2 MONTHS. PHYSICAL EXAMINATION REVEALED MESH EXPOSURE, GRANULATION, BLEEDING MESH COMPLICATION, ALONG WITH A SHORTENED VAGINA. DIGITAL EXAMINATION INDICATED THE PRESENCE OF FIRM INFILTRATIONS. SMEARS FOR CONVENTION MICROBIOLOGICAL EXAMINATION REVEALED AN ABUNDANCE OF ESCHERICHIA COLI. THE PATIENT UNDERWENT MESH REMOVAL UNDER GENERAL ANESTHESIA WITH ANTIBIOTICS COVER. DURING SURGERY, SINUS FORMATION WAS IDENTIFIED. THE MESH WAS EASILY REMOVED UP TO THE LATERAL PELVIC WALL AND SENT FOR HISTOLOGICAL EXAMINATION WHICH REVEALED ACTINOMYCOTIC INFECTION. THE PATIENT RECEIVED LONG-TERM ANTIBIOTIC TREATMENT (AMOXICILLIN FOR 6 MONTHS, 1G EVERY 8H). AFTER ANTIBIOTIC TREATMENT, PAIN AND INFILTRATIONS OF ANTERIOR VAGINAL WALL DISAPPEARED. IT WAS SUGGESTED THAT EXPOSED MESH WAS SECONDARY INFECTED WITH COMMON VAGINAL FLORA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821210 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention