BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3033234 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03397
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODES: 67, 92 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 THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-03392 AND MEDWATCH 2210968-2013-03393. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2009 AND (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH BURCH CYSTOURETHROPEXY, PARAVAGINAL DEFECT REPAIR, ABDOMINOSACRAL COLPOPEXY, AND SUPRAPUBIC TELOSCOPY DUE TO SYMPTOMATIC PELVIC RELAXATION AND GENUINE STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT CLIPPING OF MESH GOING INTO VAGINA ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REVISION/REMOVAL AND IMPLANTATION OF AN AUTOLOGOUS SLING ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY LEAKAGE, URINARY URGENCY, URINARY FREQUENCY, URINARY RETENTION, URINARY TRACT INFECTION, NOCTURIA, AND INCONTINENCE. IT WAS REPORTED THAT PATIENT UNDERWENT COAPT-TYPE URETHRAL BULKING AND REMOVAL OF SEBACEOUS CYST ON (B)(6) 2009 BY DR. (B)(6) DUE TO STRESS URINARY INCONTINENCE, DETRUSOR OVERACTIVITY, AND SEBACEOUS CYST OF THE VULVA. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY WITH URETHRAL BULKING COAPTITE INJECTIONS ON (B)(6) 2009 BY DR. (B)(6) DUE TO INTRINSIC SPHINCTER DEFICIENCY, STRESS INCONTINENCE, AND OVERACTIVE BLADDER. IT WAS REPORTED THAT PATIENT UNDERWENT VULVAR BIOPSY, LASER ABLATION OF MULTIPLE VULVAR LESIONS GREATER THAN 20, AND CYSTOSCOPY ON (B)(6) 2010 BY DR. (B)(6) DUE TO DETRUSOR OVERACTIVITY, DYSURIA, AND VULVAR LESIONS AT (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT TRANSVAGINAL URETHROLYSIS AND CYSTOCELE REPAIR ON (B)(6) 2014 BY DR. (B)(6) DUE TO INCOMPLETE BLADDER EMPTYING AND URETHRAL OBSTRUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2004 AND (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY LEAKAGE, URINARY URGENCY, URINARY FREQUENCY, URINARY RETENTION, URINARY TRACT INFECTION, NOCTURIA, AND INCONTINENCE. IT WAS REPORTED THAT PATIENT UNDERWENT COAPT-TYPE URETHRAL BULKING AND REMOVAL OF SEBACEOUS CYST ON (B)(6) 2009 BY DR. (B)(6) DUE TO STRESS URINARY INCONTINENCE, DETRUSOR OVERACTIVITY, AND SEBACEOUS CYST OF THE VULVA. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY WITH URETHRAL BULKING COAPTITE INJECTIONS ON (B)(6) 2009 BY DR. (B)(6) DUE TO INTRINSIC SPHINCTER DEFICIENCY, STRESS INCONTINENCE, AND OVERACTIVE BLADDER. IT WAS REPORTED THAT PATIENT UNDERWENT VULVAR BIOPSY, LASER ABLATION OF MULTIPLE VULVAR LESIONS GREATER THAN 20, AND CYSTOSCOPY ON (B)(6) 2010 BY DR. (B)(6) DUE TO DETRUSOR OVERACTIVITY, DYSURIA, AND VULVAR LESIONS AT (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT TRANSVAGINAL URETHROLYSIS AND CYSTOCELE REPAIR ON (B)(6) 2014 BY DR. (B)(6) DUE TO INCOMPLETE BLADDER EMPTYING AND URETHRAL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136244 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1348692

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention