BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3200954 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11833
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    August 17, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR AND POSTERIOR REPAIR AND INTRAPERITONEAL COLPOPEXY VIA HIGH UTEROSACRAL LIGAMENT SUSPENSION DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING REVISION AND CYSTOSCOPY ON (B)(6) 2011 DUE TO BLADDER SPASMS AND A FEELING OF INCOMPLETE BLADDER EMPTYING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2011. (B)(4).

    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). 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) 2011 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303104 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3509544

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention