BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2770562 · Received October 3, 2012

    Report

    Report Number
    2210968-2012-05893
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A VAGINAL HYSTERECTOMY CONCURRENTLY WITH THE PROCEDURE. IN (B)(6) 2008, THE PATIENT UNDERWENT A MESH REVISION PROCEDURE DUE TO EROSION AND DYSPAREUNIA. ON AN UNKNOWN DATE IN 2009, THE PATIENT UNDERWENT A MESH REVISION PROCEDURE DUE TO EROSION, SCAR TISSUE AND DYSPAREUNIA. ON (B)(6) 2010, THE PATIENT UNDERWENT A VAGINAL SCAR TISSUE REVISION PROCEDURE DUE TO CONTINUING PROBLEMS WITH DYSPAREUNIA. ON (B)(6) 2012, THE PATIENT UNDERWENT MESH EXPLANTATION DUE TO EROSION, PAIN AND INFECTION. (B)(4) - DYSPAREUNIA. 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR/POSTERIOR REPAIR WITH SACROSPINOUS LIGAMENT FIXATION USING SUTURES, AND MESH REMOVAL ON (B)(6) 2012 DUE TO EXPOSURE AND POP AND ANTERIOR REPAIR USING SUTURES AND MESH REMOVAL ON (B)(6) 2013 DUE TO OBSTRUCTING SLING AND CYSTOCELE. NO ADDITIONAL INFORMATION WAS 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-05892. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3146789

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention