BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3242764 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14152
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    March 7, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH TAH AND CYSTOSCOPY ON (B)(6) 2005 DUE TO PELVIC PAIN AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH A CYSTOSCOPY ON (B)(6) 2007 DUE TO VAGINAL VAULT PROLAPSE AND SUI AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED WORSENING INCONTINENCE, WORSENING LEAKAGE, SEVERE/SIGNIFICANT VAGINAL SCARRING, RECURRENT URINARY TRACT INFECTIONS, MULTIPLE SURGICAL PROCEDURES, URGE INCONTINENCE, ELEVATED WHITE BLOOD CELL COUNT, FOUL SMELLING URINE, LOWER BACK PAIN, NOCTURIA, FREQUENCY, VAGINAL DISCHARGE, LOWER BACK PAIN RADIATING TO LEGS AND THIGHS, CONSTIPATION, VAGINAL PAIN, VAGINAL BLEEDING, BLEEDING WITH INTERCOURSE, DYSPAREUNIA, HYPERGRANULATION TISSUE, RECTAL BLEEDING, PELVIC PAIN, INFLAMMATORY CHANGES IN PELVIS AND COLON, FREE FLUID IN PELVIS, RECURRENT PROLAPSE, INCOMPLETE VOIDING, LEFT LOWER QUADRANT ADHESIONS, MESH EROSION, EXPOSURE AND EXTRUSION, HEMATURIA, CONSTIPATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2006 FOR DYSPAREUNIA, PELVIC-LOWER BACK AND ABDOMINAL PAIN, ADHESIONS, MESH EROSION, MESH EXPOSURE AND EXTRUSION, COLON INFLAMMATION, FREE FLUID IN PELVIS, RECURRENT UTIS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY, TEMPORARY RIGHT OPEN-ENDED CATHETER PLACEMENT, VAGINAL EXCISION OF SLING MATERIAL AND VAGINAL EXCISION OF GRAFT MATERIAL ON (B)(6) 2013 DUE TO PELVIC PAIN, URINARY FREQUENCY, URGENCY AND URGE INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. ON (B)(6) 2010, AMS MONARC SLING WAS IMPLANTED. 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
    344245 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3000736

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention