BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3202621 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11933
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    July 29, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, EROSION, AND OTHER SYMPTOMS ATTRIBUTED TO THE MESH IMPLANT. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION WITH BURCH PROCEDURE IN 2009 DUE TO PAIN, FAILURE OF MESH, AND PROLAPSE. THE PATIENT UNDERWENT A HYSTERECTOMY IN (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) -URINARY PROBLEMS; FAILURE OF MESH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY, URINARY FREQUENCY AND HEMATURIA. IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT TVH-BSO, UTEROSACRAL LIGAMENT VAGINAL VAULT SUSPENSION AND PARAVAGINAL DEFECT REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH AND BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH WERE 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
    302153 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2917078

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention