BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2931309 · Received January 28, 2013

    Report

    Report Number
    2210968-2013-00559
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY FULGURATION IN 2004 AND 2009. IT WAS REPORTED THAT THE PATIENT UNDERWENT INSERTION OF DRUG IMPLANT DEVICE IN 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CERVICAL STUMPECTOMY, REPAIR OF ENTEROCELE WITH BILATERAL UTEROSACRAL LIGAMENT COLPOPEXY, EXTENSIVE LYSIS OF CUL-DE-SAC ADHESIONS FROM THE COLON, POSTERIOR COLPOPERINEORRHAPHY USING MESH AND CYSTOSCOPY. IT WAS REPORTED THAT PATIENT HAD A BLADDER BIOPSY, BLADDER OVERDISTENTION AND CYSTOSCOPY ON 03/10/2004 DUE TO CHRONIC INTERSTITIAL CYSTITIS.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT RECURRENT CYSTOCELE, ENTEROCELE, RECTOCELE, CERVICAL PROLAPSE WITH STRESS URINARY INCONTINENCE AND HYPERMOBILE URETHROVESICAL FUNCTION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL/REVISION ON (B)(6) 2009.

    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 2210968-2013-00558. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT 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
    36588 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1092431

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention