BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3182107 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10723
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    October 7, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING AND OTHER. IT WAS REPORTED THAT PATIENT UNDERWENT STAGE I INCISIONAL IMPLANTATION OF NEUROSTIMULATOR LEAD ON (B)(6). 2013. IT WAS REPORTED THAT PATIENT UNDERWENT INTERSTIM NEUROSTIMULATOR IMPLANT AND PROGRAMMING PHASE II ON (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 10/9/2016.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT PATIENT UNDERWENT TAH/BSO AND ENTEROLYSIS OF PELVIC ADHESIONS ON (B)(6) 2012 DUE TO CHRONIC PELVIC PAIN WITH PELVIC ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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
    282194 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK 3453211

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention