BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2080381 · Received May 6, 2011

    Report

    Report Number
    2210968-2011-00586
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SINCE IMPLANTATION OF THE MESH, THE PATIENT HAS EXPERIENCED PAIN AND INJURY AND HAS HAD NUMEROUS CORRECTIVE SURGICAL PROCEDURES. THE PATIENT EXPERIENCED AN EROSION AND UNDERWENT AN EXCISION OF THE MESH, REVISION OF CYSTOCELE REPAIR; RECTOCELE REPAIR WITH MESH RE-DO, AND A PUBOVAGINAL SLING ON (B)(6) 2009. THE (B)(6) 2009 SURGERY INVOLVED A MICROVASIVE PRECISION TWIST DEVICE TO PLACE BONE ANCHORS ON EITHER SIDE OF THE PUBIC SYMPHASIS. A REPLIFORM TISSUE WAS SECURED TO THE WOUND WITH SUTURES AND LOOSENED TO ALLOW AN EASY PASS UNDER THE URETHRA WITH NO TENSION. (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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2011-00587. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2011-00587. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2008 IN ORDER TO TREAT CYSTOCELE, STRESS URINARY INCONTINENCE, AND RECTOCELE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN/DYSPNEA IN 2009 AND UNDERWENT A NERVE BLOCK IN 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL DISC FUSION AND EXPERIENCED A RIGHT AND LEFT MEDIAL MENISCUS TEAR IN 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, DRIBBLING, PRESSURE, PROLAPSE, URINARY URGENCY AND URINARY INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR A GRADE 3 CYSTOCELE AND STRESS INCONTINENCE ON (B)(6) 2008, AND A BOSTON SCIENTIFIC PINNACLE MESH AND A SLING WERE IMPLANTED. ON (B)(6) 2008, THE SURGEON ATTEMPTED TO TRIM PORTIONS OF THE MESH THAT HAD BEEN IMPLANTED BECAUSE IT WAS PROTRUDING THROUGH THE PATIENT'S VAGINA. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, DRIBBLING, PRESSURE, PROLAPSE, URINARY URGENCY AND URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON NA 3128530

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention