BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3100439 · Received May 8, 2013

    Report

    Report Number
    2210968-2013-05294
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE, AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL REMOVAL OF ERODED SLING AND REPAIR OF LACERATED BLADDER ON (B)(6) 2005 DUE TO EROSION OF SLING AND LACERATION OF BLADDER. IT WAS REPORTED THAT THE PATIENT UNDERWENT RECONSTRUCTION OF URETHRA/FEMALE URETHROPLASTY, CYSTOSCOPY ON (B)(6) 2006 DUE TO URETHRAL EROSION CAUSED BY PREVIOUS MESH IMPLANT, SUI AND RECURRENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2005 AND MENTOR TRANS-OBTURATOR TAPE WAS IMPLANTED. 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
    201859 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1098887

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention