BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2913018 · Received January 14, 2013

    Report

    Report Number
    2210968-2013-00261
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 19, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4). 2013. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005 CONCURRENTLY WITH HYSTERECTOMY DUE TO UTERINE VAGINAL PROLAPSE, AND GENUINE STRESS INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN DISCOMFORT, STRAINED BOWEL MOVEMENT, HOLES IN THE VAGINAL WALL FROM MESH EROSION ALSO BURNING, VAGINAL SCARRING, AND BLEEDING AFTER SEX. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR MESH COMPLICATIONS AND HAD AMS MINI ARC REPAIR SYSTEM IMPLANTED INTO THE PATIENT ON 08/28/2009. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION DUE TO EROSION ON (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2005 AND (B)(6) 2009 AND A SLING AND AN AMS MINIARC REPAIR SYSTEM WERE IMPLANTED. IT IS UNKNOWN ON WHICH DATE EACH DEVICE WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21398 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention