BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3071330 · Received April 22, 2013

    Report

    Report Number
    2210968-2013-04252
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT POST IMPLANTATION PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND URINARY PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT THE FOLLOWING REVISIONARY PROCEDURES: (B)(6) 2010¿ REVISION OF VAGINAL MESH DUE TO EROSION; (B)(6) 2012- REVISION OF EXPOSED MESH AND HYSTERECTOMY; (B)(6) 2012¿ CYSTOSCOPY, LEFT URETEROSCOPY, LEFT URETERAL STENT INSERTION AND TRANSURETHRAL RESECTION OF BLADDER LESION. (B)(4) ¿ EXTRUSION; RECURRENCE; DYSPAREUNIA; URINARY PROBLEMS.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. 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
    171260 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3352344

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention