BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2881371 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08160
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERMESH MESH IMPLANTATION IN ORDER TO TREAT CYSTOCELE, RECTOCELE AND VAULT PROLAPSE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A SACROCOLPOPEXY WITH ANTERIOR AND POSTERIOR MESH EXTENSIONS, ADDITIONAL MESH IMPLANTATIONS AND AN ENTEROCELE REPAIR DURING MESH IMPLANTATION. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-08159, 2210968-2013-14447, AND 2210968-2013-14444. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAULT PROLAPSE, A GRADE 3 CYSTOCELE, AND A GRADE 2 RECTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, BLEEDING AND OTHER PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXAM UNDER ANESTHESIA ON (B)(6) 2011 AND CYSTOSCOPY AS WELL AS VAGINOSCOPY WAS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): 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 AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-08159. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE ADDITIONAL 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 1325025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention