BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2945613 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00729
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REPAIR ON (B)(6) 2011. ON (B)(6) 2012 PATIENT UNDERWENT A LAPAROSCOPY.

    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 2210968-2013-00730. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR AND POSTERIOR REPAIR WITH ENTEROCELE REPAIR, PARTIAL COLPOCLEISIS AND CYSTOURETHROSCOPY ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2011 CONCURRENTLY WITH VAGINAL PARAVAGINAL REPAIR, RECTOCELE REPAIR, INSERTION OF MESH INTO ANTERIOR/POSTERIOR COMPARTMENTS, AND SACROSPINOUS COLPOPEXY IN ORDER TO TREAT LATERAL CYSTOCELE, WEAKNESS OF THE PUBOCERVICAL FASCIA, RECTOCELE, WEAKNESS OF THE RECTOCERVICAL FASCIA, AND STRESS URINARY INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ROBOT ASSISTED LAPAROSCOPIC ENTEROLYSIS WITH EXTENSIVE LYSIS OF ADHESIONS, SACROCOLPOPEXY, PARAVAGINAL REPAIR, RECTOCELE REPAIR WITH A POSTERIOR COMPARTMENT REPAIR, URETHROLYSIS, CYSTOURETHROSCOPY, HIATAL U SHAPE COLLAGEN MESH IMPLANT, AND (CALDERA) DESARA SLING IMPLANT ON (B)(6) 2012 DUE TO POP, SUI, AND WEAKENING OF PUBOCERVICAL AND RECTOCERVICAL TISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL COLPOCLEISIS ON (B)(6) 2011. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 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 ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49998 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3521148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention