BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2803134 · Received October 24, 2012

    Report

    Report Number
    2210968-2012-06868
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION (B)(6) 2011 AND (B)(6) 2012 DUE TO MESH EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION SURGERIES BY IMPLANTING SURGEON ON (B)(6) 2011. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED A VAGINAL PAIN, INCONTINENCE AND BOWELS PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF COOK SUPRA PUBIC ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION (B)(6) 2011 AND (B)(6) 2012 DUE TO MESH EROSION.

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-05286 AND MEDWATCH 2210968-2012-05287. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: (B)(4) 2013. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION SURGERIES BY THE IMPLANTING SURGEON ON (B)(6) 2011, (B)(6) 2011, AND (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH COOK SUPRA PUBIC MESH DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED A VAGINAL PAIN, INCONTINENCE AND BOWELS PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF COOK SUPRA PUBIC ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3447234

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention