BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2892223 · Received January 2, 2013

    Report

    Report Number
    2210968-2013-00010
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    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). 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 2210968-2012-2210968-2012-07395. 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH A & P COLPORRHAPHY, REVISION OF SUBURETHRAL SLING, REVISION AND EXCISION OF ANTERIOR PLACED VAGINAL MESH AND POSTERIOR REVISION OF POSTERIORLY PLACED VAGINAL MESH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF SUBURETHRAL MESH, REVISION/EXCISION OF ANTERIOR PLACED VAGINAL MESH, ANTERIOR COLPORRHAPHY, CYSTOURETHROSCOPY, POSTERIOR REVISION OF POSTERIORLY PLACED VAGINAL MESH, POSTERIOR COLPORRHAPHY ON (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010. 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
    1299 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3422081

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention