BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3092641 · Received May 3, 2013

    Report

    Report Number
    2210968-2013-04956
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REVISION ON (B)(6) 2006.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOURETHROSCOPY DUE TO MENOMETRORRHAGIA AND URETHRAL HYPERMOBILITY. THE PATIENT EXPERIENCED PAIN, BLEEDING, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING, FISTULAE AND OTHER. IT WAS REPORTED THAT PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS AND LEFT SALPINGO-OOPHORECTOMY ON (B)(6) 2007. (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.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY, URGENCY AND NOCTURIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2006 BY (B)(6) DUE TO URINARY RETENTION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION OF MID URETHRAL SLING MESH AND CYSTOSCOPY ON (B)(6) 2016 BY (B)(6) FOR PELVIC PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH 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.

    Description of Event or Problem · 1

    DETAILS: IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION OF MID URETHRAL SLING MESH AND CYSTOSCOPY ON (B)(6) 2016 BY (B)(6) FOR PELVIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193952 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC NA 1328586

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention