BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3121528 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05690
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 24, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO URETHRAL MESH TO LIFT BLADDER. THE PATIENT EXPERIENCED SEVERAL YEARS OF URINARY TRACT INFECTIONS AFTER THE IMPLANT, SEVERE PAIN IN THE UTERINE AREA, SOME URINARY INCONTINENCE, STRESSED ABOUT SURGERY TO REMOVE THE IMPLANT, SOME BLEEDING, BLOOD IN URINE, PIN, BURNING ITCHING, PAINFUL INTERCOURSE AND LEAKAGE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH IN 2009 OR 2010 TO PRESENT. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 AND CORRECTIVE SURGERY ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES, AND 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
    224120 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1379000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention