BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2870596 · Received December 12, 2012

    Report

    Report Number
    2210968-2012-08079
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT INTRINSIC SPHINCTER DEFICIENCY, SUB-PELVIC RELAXATION, AND AN OVARIAN CYST OF 10 CENTIMETERS. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF BILATERAL SALPINGO-OOPHORECTOMY AND LYSIS OF ADHESIONS DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2010 FOR MESH EXPOSURE AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF AN INJECTION OF STEROIDS NEAR PUDENDAL NERVE, CYTOSCOPY AND CUT DEEP ANTERIOR PASS DURING MESH REVISION.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-08080. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 DUE TO EXPOSURE AND VAGINAL PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINITIS. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2013 BY DR. (B)(6) DUE TO VAGINAL PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2903899

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention