BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3181281 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10697
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. ON (B)(6) 2008 EXCISION OF EXPOSED VAGINAL MESH WAS PERFORMED DUE TO EXPOSED MESH. ON (B)(6) 2008 REMOVAL OF EXPOSED VAGINAL MESH WAS ATTEMPTED DUE TO VAGINAL PAIN AND IRRITATION AND DYSPAREUNIA. ON (B)(6) 2008 EXCISION OF EXPOSED VAGINAL MESH WAS PERFORMED DUE TO EXPOSED MESH. NO ADDITIONAL INFORMATION WAS PROVIDED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND ALSO ON (B)(6) 2008 AND MESH WAS IMPLANTED DURING EACH SURGERY. 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
    282297 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3030490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention