BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2772215 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-05821
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 14, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY, REMOVAL OF MESH AND FULGURATION OF BLEEDING SITE ON (B)(6) 2004 DUE TO BLADDER LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATENT DIED ON (B)(6) 2016 DUE TO LUNG CANCER.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013. IT WAS REPORTED THAT POST IMPLANTATION THE PATIENT EXPERIENCED RECURRENCE OF PAIN, EROSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT HAD SURGERY TO REMOVE MATERIAL FROM THE MESH ALONG WITH BIOPSY AND FULGURATION OF BLADDER LESION ON (B)(6) 2008 DUE TO URGENCY, RECURRENT INFECTION, AND HEMATURIA. SHE ALSO HAD A CYSTOSCOPY PROCEDURE ON (B)(6) 2009 IN ORDER TO REMOVE RETAINED MESH DUE TO RECURRENT URINARY TRACT INFECTIONS. THE PATIENT ALSO HAD A HERNIA REPAIR ON (B)(6) 2012. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME. (B)(4). 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 ON (B)(6) 2003 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 1081413

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention