BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972928 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01568
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE, CYSTOCELE AND RECTOCELE. THE PATIENT UNDERWENT A TRANSABDOMINAL URETHROLYSIS SECONDARY TO URETHRAL OBSTRUCTION ON (B)(6) 2004 DUE TO ANTERIOR CYSTOPEXY. THE PATIENT UNDERWENT AN INTERSTIM BLADDER IMPLANT IN 2006. THE PATIENT UNDERWENT A PARTIAL NEPHRECTOMY IN 2008.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT VAGINAL EXAM UNDER ANESTHESIA, REMOVAL OF GRANULATION TISSUE, AND URETHROLYSIS ON (B)(6) 2004 BY DR. (B)(6) DUE TO POSSIBLE EROSION OF PUBOVAGINAL SLING INTO THE VAGINA, VAGINAL DISCHARGE, AND URINARY RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND A SLING AND PELVICOL WERE IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT VAGINAL EXAM UNDER ANESTHESIA, REMOVAL OF GRANULATION TISSUE, AND URETHROLYSIS ON (B)(6) 2004 BY DR. (B)(6) DUE TO POSSIBLE EROSION OF PUBOVAGINAL SLING INTO THE VAGINA, VAGINAL DISCHARGE, AND URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77211 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1100637

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention