BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2831109 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07115
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND VAGINAL VAULT PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, RECURRENCE, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING AFTER MESH IMPLANTATION. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO EXTREME SWELLING OF VAGINA AND PELVIC REGION WITH RECTAL PAIN. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND A SLING AND AMS - INTERPRO LARGE PORE POLYPROPYLENE AND Y-SLING WERE 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3425150

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention Y-SLING