BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3161894 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10057
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    February 22, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2008 ALONG WITH HYSTERECTOMY DUE TO SUI, SYMPTOMATIC CYSTOURETHOCELE, POSTERIOR VAGINAL VAULT PROLAPSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT 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
    262308 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3040618

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention