BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2920823 · Received January 17, 2013

    Report

    Report Number
    2210968-2013-00366
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 26, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE AND BLADDER PROLAPSE. IT WAS REPORTED THAT AFTER IMPLANTATION PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, RECURRENCE, BLEEDING, VAGINAL SCARRING, ORGAN PERFORATION AND URINARY PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPIES ON (B)(6) 2006 DUE TO EXPOSURE AND ORGAN PERFORATION EXACERBATED BY BLADDER STONES AND ON (B)(6) 2006 DUE TO BLADDER STONES ADHERING TO BLADDER WALL WITH EXPOSED SLING MESH UNDERNEATH. IT WAS REPORTED THE PATIENT EXPERIENCED CALCULI ATTACHED TO LEFT LATERAL WALL OF BLADDER WITH EXPOSED MESH ON (B)(6) 2007 SHE UNDERWENT CYSTO CYSTOLITHOPEXY AND FULGURATION BLADDER. IT WAS REPORTED THE PATIENT UNDERWENT CYSTOLITHOPEXY, CYTOSCOPY AND LASER LITHOTRIPSY OF BLADDER STONE ON (B)(6) 2012 DUE TO BLADDER STONE THAT FORMED IN BLADDER SUSPENSION. (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.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 5/5/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT POSTERIOR COLPORRHAPHY AND ENTEROCELE REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS USED. THE PATIENT EXPERIENCED MESH EROSION, PAIN, INFECTION, DYSPAREUNIA AND OTHER INJURIES FOLLOWING THE PROCEDURE, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT POSTERIOR COLPORRHAPHY AND ENTEROCELE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26534 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 998053

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention