BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3242976 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14193
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. A CYSTOSCOPY WAS PERFORMED CONCURRENTLY WITH PROCEDURE DUE TO POP AND SUI. PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, ORGAN PERFORATION, BLEEDING, AND DYSPAREUNIA. NO ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    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

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED. A CYSTOSCOPY WAS PERFORMED CONCURRENTLY WITH PROCEDURE DUE TO POP AND SUI. PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, ORGAN PERFORATION, BLEEDING, AND DYSPAREUNIA. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, PRESSURE, DIFFICULTY VOIDING URINE, CONTINUED INCONTINENCE, DISCHARGE, SCARRING, INFECTION, ODOR, BLEEDING, 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
    342070 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3379938

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention