BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3162276 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-06980
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TVH, UTEROSACRAL VAGINAL SUSPENSION REVISION OF MESH PLACEMENT RECTOCELE ON (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2009 DUE TO PELVIC PAIN AND DYSPAREUNIA. ON (B)(6) 2009, THE PATIENT UNDERWENT TOTAL VAGINAL HYSTERECTOMY, UTEROSCARAL VAGINAL SUSPENSION, REVISION OF MESH AND RECTOCELE. ON (B)(6) 2010, THE PATIENT UNDERWENT EXCISION OF MESH, PLACEMENT OF BARD SOFT MESH AND AMS SPARC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH AND POLYFORM WERE IMPLANTED. IT WAS REPORTED THAT 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
    262259 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3113679

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention