BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2933020 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00617
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED, CONCURRENTLY WITH A DIAGNOSTIC LAPAROSCOPY, LAPAROTOMY, SALPINGO OOPHORECTOMY, AND APPENDECTOMY DUE TO STRESS URINARY INCONTINENCE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED, CHRONIC PELVIC AND VAGINAL PAIN, PUNGENT VAGINAL DISCHARGE, VAGINAL BLEEDING, VAGINAL AND BLADDER INFECTIONS, PROTRUSION, SWELLING, SCARRING, SEVERELY PAINFUL INTERCOURSE, DISCOMFORT, EXCESSIVE SCAR TISSUE, ABDOMINAL PAIN, STOMACH PAIN, URINE LEAKAGE, FREQUENCY TO URINATE, PUNGENT URINE, INABILITY TO HAVE INTIMACY, POOR OVERALL QUALITY OF LIFE, MESH EROSION, URINARY INCONTINENCE, SEVERE DEPRESSION, AND SEVERE INJURIES RELATED TO MESH DEVICE. IT WAS REPORTED THAT THE PATIENT HAD MESH TRIMMED IN (B)(6) 2009, (B)(6) 2009, (B)(6) 2009, AND (B)(6) 2009. THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    39674 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3081328

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention