BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3103313 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05374
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE, SYMPTOMATIC CYSTOCELE AND RECTOCELE. CONCOMITANTLY THE PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR COLPORRHAPHY. FOLLOWING INSERTION IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. OTHER: HEAVY CHRONIC BLEEDING, SEVERE CRAMPING, ER VISITS, CHRONIC KIDNEY INFECTIONS, DETACHMENT OF MESH RESULTING IN INTERNAL TEARING, LOWER BACK PAIN, CHRONIC INFECTIONS, BLADDER SPASMS, MIGRATION OF PIECES OF MESH TO OTHER ORGANS, PELVIC FLOOR THERAPY, HOMEBOUND, MARITAL DISCORD, DEPRESSION. IT WAS REPORTED THAT THE REPAIR AND PARTIAL MESH REMOVAL THAT WAS DONE ON (B)(6) 2011 DUE TO VAGINAL TEARING, BLEEDING AND INFECTION. IT WAS FURTHER REPORTED THAT THE PARTIAL EXPLANT THAT WAS DONE ON (B)(6) 2012 WAS DONE DUE TO EROSION, MESH SEPARATION, BLEEDING, CHRONIC INFECTIONS AND BLADDER SPASMS. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, NOCTURIA, HEMATURIA, URINARY TRACT INFECTION, AND URINARY INCONTINENCE. (B)(4).

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01748. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING PAIN, EROSION, FORMATION OF SCAR TISSUE, INFECTION, BLEEDING, VAGINAL TEARING, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. SHE UNDERWENT MESH REMOVAL SURGERIES ON (B)(6) 2011 AND (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203003 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3146786

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention