BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2870473 · Received December 12, 2012

    Report

    Report Number
    2210968-2012-08060
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE ON (B)(6) 2010. THIS PROCEDURE WAS COMPLICATED BY INTRA-VESICLE PENETRATION, BLADDER PERFORATION, AND MESH EXPOSURE, WHICH REQUIRED EXCISION 24 HOURS LATER ON (B)(6) 2010. IT IS ALSO REPORTED THAT ON (B)(6) 2010 THE PATIENT STATED THAT, ¿SHE CUT SOME STITCHES OUT FROM HER ABDOMINAL SIDE AND THAT SHE CAN STILL FEEL THE VAGINAL STITCHES.¿ ON (B)(6) 2010, PATIENT UNDERWENT EXCISION OF MESH. PATIENT HAD SUBSEQUENTLY UNDERGONE REMOVAL OF ANOTHER PORTION OF IMPLANT ON (B)(6) 2011. AS OF (B)(6) 2012 IT WAS REPORTED THAT PATIENT IS BACK TO HAVING SYMPTOMS OF STRESS INCONTINENCE WITH LEAKAGE UPON EXERTION ACTIVITIES. IT WAS REPORTED THAT FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, RECURRENT INFECTION, URINARY AND BOWEL PROBLEMS, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, ORGAN PERFORATION AND VAGINAL SCARRING. (B)(4) ¿ URINARY PROBLEMS; BOWEL PROBLEMS; DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT UNDERWENT CYSTOSCOPY ON (B)(6) 2010 DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THE PATIENT IS S/P REMOVAL OF VAGINAL MESH AND CYSTOSCOPY [(B)(6) 2011] AND ON (B)(6) 2012 SHE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT AND INCONTINENCE AND REMAINED ON HYDROCODONE FOR PAIN (B)(6) 2012 - (B)(6) 2012 AND IS PLANNING ADDITIONAL BLADDER SURGERIES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. (B)(4).

    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

    IT WAS REPORTED THAT ARIS TRANS-OBTURATOR WAS IMPLANTED ON (B)(6) 2012 DUE TO SUI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARIS TRANS-OBTURATOR WAS IMPLANTED ON (B)(6) 2012 DUE TO SUI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3379917

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention