BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2931340 · Received January 28, 2013

    Report

    Report Number
    2210968-2013-00577
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2004 DUE TO INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EROSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA AND NEUROMUSCULAR PROBLEMS. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL ON (B)(6) 2012 DUE TO MESH DETERIORATION AND INFECTION. (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. (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2013 DUE TO VOIDING DYSFUNCTION, MECHANICAL COMPLICATION OF IMPLANTED DEVICE, AND VAGINAL ATROPHY. (B)(4) - VOIDING DYSFUNCTION; VAGINAL ATROPHY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED OVERACTIVE BLADDER, FREQUENCY, URGENCY, URGE INCONTINENCE, URETHRAL OBSTRUCTION, HESITANCY, INCOMPLETE BLADDER EMPTYING AND RECURRENT URINARY TRACT INFECTIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PELVIC SPASMS AND PYURIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS USED. THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND H. ELEVATE WAS USED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PELVIC SPASMS AND PYURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36620 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1101933

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention