BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2882814 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08216
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 2, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPY WITH LYSIS OF ADHESIONS AS WELL AS EXCISION OF ENDOMETRIOSIS PERITONEAL IMPLANTS ON (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL MESH IMPLANTATION ALONG WITH THE CONCURRENT PROCEDURE OF A LAPAROSCOPIC HYSTERECTOMY WITH CYSTOSCOPY DURING MESH IMPLANTATION ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF VAGINAL MESH ON (B)(6) 2011 DUE TO DYSPAREUNIA AND LEG PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION, SLING REVISION AND CYSTOSCOPY ON (B)(6) 2011 DUE TO MESH EROSION, PERSISTENT URINARY INCONTINENCE, DYSPAREUNIA AND PELVIC PAIN. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-08215. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT LOA.

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-08215. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES ON (B)(6) 2007 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 FTL ETHICON, INC. NA 3005483

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention