BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2920756 · Received January 17, 2013

    Report

    Report Number
    2210968-2013-00431
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, EXTRUSION, RECURRENCE, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY AND VAGINAL MESH REVISION ON (B)(6) 2011 FOR PAIN AND MESH EXPOSURE. ON (B)(6) 2002, THE PATIENT EXPERIENCED SMALL VAGINAL SEPARATION AND EXPOSED AREA OF MESH, AN EXCISION MADE WITH SUTURE REMOVAL SCISSOR. SHE THEN EXPERIENCED A SMALL VAGINAL AREA OF SEPARATION (2 MM), THIS WAS CLEANSED WITH BETADINE AND CLOSED WITH SUTURE ON (B)(6) 2002. ONE WEEK S/P SUTURING OF VAGINA, THE PATIENT EXPERIENCED EXPOSED MESH AND WAS RE-SUTURED ON (B)(6) 2002. ON (B)(6) 2002, THE VAGINAL EXAM OF THE PATIENT SHOWED SATISFACTORY HEALING OF THE SMALL SEPARATION IN ANTERIOR VAGINAL WALL AND APPEARED TO BE FREE OF INFECTION. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2002. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26380 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 914645

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention