BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3250836 · Received July 29, 2013

    Report

    Report Number
    2210968-2013-14712
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    May 29, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE PATIENT UNDERWENT INJECTION WITH LIDOCAINE AND AREA WAS OVER SEWN ON (B)(6) 2011 DUE TO POSTERIOR VAGINAL WALL MESH EXPOSURE AND SHARP GROIN PAIN. 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). 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) ¿ MESH EXPOSURE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED UTI, INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR POSTERIOR COLPORRHAPHY AND CYSTOSCOPY DUE TO UTERINE PROLAPSE, STRESS URINARY INCONTINENCE, CHRONIC URINARY TRACT INFECTIONS, AND CHRONIC BACK PAIN. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, PAIN, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. IT WAS REPORTED ON (B)(6) 2012, THE PATIENT EXPERIENCED SEVERE PAIN IN VAGINA, PAIN IN ABDOMEN AND SHARP SHOOTING PAIN WITH URINATION. SHE STATED THE MESH IS CUTTING HER AND IS NOT ABLE TO HAVE INTERCOURSE. SHE RESTARTED ON PREMARIN VAGINAL CREAM AND ON (B)(6) 2012 WAS SEEN BY DOCTOR FOR SUTURE EXPOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    FROM PRODUCT ISSUE (B)(4). (B)(4) RECEIVED AN E-MAIL FROM THE ETHICON RISK MANAGER STATING THE FOLLOWING:IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2011 AND PROLIFT WAS PLACED INTO THE PATIENT¿S BODY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. UPDATED INFORMATION RECEIVED ON (B)(6) 2013: IT WAS REPORTED THE PATIENT UNDERWENT ANTERIOR/POSTERIOR COLPORRHAPHY AND CYSTOSCOPY. PROLIFT M AND GYNECARE TVT-O WERE IMPLANTED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED ON (B)(6) 2012 THE PATIENT EXPERIENCED SEVERE PAIN IN VAGINA, PAIN IN ABDOMEN AND SHARP SHOOTING PAIN WITH URINATION. SHE STATED THE MESH IS CUTTING HER, CUT HER HUSBAND¿S PENIS AND NOT ABLE TO HAVE INTERCOURSE. SHE WAS RESTARTED ON PREMARIN VAGINAL CREAM AND ON (B)(6) 2012 WAS SEEN BY MD FOR SUTURE EXPOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED. UPDATED INFORMATION RECEIVED ON (B)(4) 2013: IT WAS REPORTED THE PATIENT EXPERIENCED POSTERIOR VAGINAL WALL MESH EXPOSURE AND SHARP GROIN PAIN, THE AREA WAS INJECTED WITH LIDOCAINE AND AREA WAS OVER SEWN ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352698 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3482939

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention