BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3113779 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05568
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 23, 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
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN IN THE VAGINA, GROIN AND LEGS, EROSION OF HER INTERNAL BODILY TISSUE, AND THE PATIENT WAS UNABLE TO URINATE WITHOUT CATHETERIZING HERSELF AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NERVE ENTRAPMENT POST MESH IMPLANT IN (B)(6) OF 2008. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. THE PATIENT HAD URINARY RETENTION WITH CHRONIC SEVERE PELVIC PAIN AND HAD MESH REMOVED ON (B)(6) 2009. THE PATIENT CONTINUES TO SELF CATHETERIZE AND TAKES DILAUDID, GABAPENTIN, AND TORADOL FOR PELVIC PAIN. ON (B)(6) 2009, THE PATIENT WAS ASSESSED WITH CHRONIC NEUROPATHIC PAIN SECONDARY TO INGUINAL NERVE AND GENERAL FEMORAL NERVE DAMAGE. NO ADDITIONAL INFORMATION PROVIDED. (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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN IN THE VAGINA, GROIN AND LEGS, EROSION OF HER INTERNAL BODILY TISSUE, UNABLE TO URINATE WITHOUT CATHETERIZING HERSELF, 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
    215570 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3128440

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention