BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2864539 · Received December 10, 2012

    Report

    Report Number
    2210968-2012-08046
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013. 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 MESH IMPLANTATION WITH CONCURRENT TOTAL VAGINAL HYSTERECTOMY AND ANTERIOR AND POSTERIOR VAGINAL REPAIR TO TREAT 3RD DEGREE UTERINE PROLAPSE, LARGE CYSTOCELE, RECTOCELE AND URINARY INCONTINENCE. POST IMPLANTATION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION AND BLEEDING. ON (B)(6) 2009 THE PATIENT UNDERWENT EXCISION OF EXPOSED VAGINAL MESH DUE TO PAIN AND DISCOMFORT. ON (B)(6) 2010 THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR PLACED IN POSTERIOR SPINE. ON (B)(6) 2010 THE PATIENT UNDERWENT PLACEMENT OF DORSAL COLUMN STIMULATOR VIA LAMINECTOMY WITH PLACEMENT OF BATTERY IN LEFT BUTTOCK USING A BOSTON SCIENTIFIC PRECISON SYSTEM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL SCARRING, INFECTION, AND VAGINAL DISCHARGE.

    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 AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-08047. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 3008591

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention