BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    MDR report key: 3233611 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13648
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    January 27, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    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). 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT ANTERIOR AND POSTERIOR REPAIR AND CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2013 BY DR. (B)(6) AT (B)(6) CENTER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT STAGE I INTERSTIM IMPLANT WITH PLACEMENT OF PERMANENT LEAD USING NEURO DIAGNOSTICS AND FLUORO GUIDANCE ON (B)(6) 2013 BY (B)(6) DUE TO URGENCY, FREQUENCY, AND HYPERTONIC MUSCLE DISORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WERE 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
    334673 GYNECARE TVT EXACT CONTINENCE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3497144

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention