BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3073472 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04316
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 5, 2013
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TRANSOBTURATOR MID-URETHRAL SLING AND CYSTOURETHROSCOPY ON (B)(6) 2014 DUE TO VAGINAL AND PELVIC PAIN.

    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. 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). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT TRANSURETHRAL INCISION OF SLING ON (B)(6) 2009, DUE TO SUI WITH RELATED SLING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED (B)(6) 2009 IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL, PELVIC AND ABDOMINAL PAIN, DIFFICULTY URINATING AND EMPTYING BLADDER, BLADDER SPASMS, CHRONIC AND RECURRENT URINARY TRACT INFECTIONS, YEAST INFECTIONS, URGENCY, VAGINAL IRRITATION, BURNING WITH URINATION, URINARY RETENTION, CHRONIC CYSTITIS, DYSPAREUNIA, PAIN FOR SEVERAL DAYS FOLLOWING INTERCOURSE, VAGINAL SCARRING, HEMATURIA, NERVE DAMAGE, WORSENING URGE AND STRESS INCONTINENCE, URETHRAL EROSION OF SLING INTO MID URETHRA, EXPOSED MESH, DYSFUNCTIONAL VOIDING, RECURRENT DYSURIA, URETHROTOMY DURING MESH REMOVAL OPERATION, PELVIC PHLEBOLITHS, OBSTRUCTING CALCIFICATIONS, RENAL CYST, PAINFUL URINATION, AND EROSION OF BLADDER SLING INTO BLADDER WALL. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISIONS ON (B)(6) 2009, (B)(6) 2012 DUE TO EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2014-00987. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE 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
    174303 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3222342

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention