BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3151319 · Received June 7, 2013

    Report

    Report Number
    2210968-2013-06696
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN, PAINFUL INTERCOURSE, FREQUENT INFECTIONS, CONTINUED URINARY INCONTINENCE, URINARY LEAKAGE, MESH EROSION, PAIN, AND TRAUMA FROM ADDITIONAL SURGERY TO REMOVE MESH DEVICE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL IN 2012 DUE TO PAIN. (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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT VAGINAL URETHROLYSIS WITH EXCISION OF SLING AND SCAR TISSUE ON (B)(6) BY (B)(6) AT (B)(6).

    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 TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252127 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3222342

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention