BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3223647 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-13000
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    September 21, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    PINNACLE PFS, PPF, AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOSULY ALLEGED, PFS ALLEGES DISCOMFORT, DIFFICULTY IN GETTING IN AND OUT OF THE CAR, AND FEELS LIKE IT DISLOCATES WHEN MOVED TOO QUICKLY ACCOMPANIED WITH INTENSE PAIN. PPF HAS NO ALLEGATION. AFTER THE REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION THAT WILL CHANGE THE MDR REPORTABILITY. THERE IS NO INFORMATION PROVIDED IN THE MEDICAL RECORDS WILL CONFIRM IMPLANT DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322703 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3398122

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention