BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2981200 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01870
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 8, 2013
    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, MENORRHAGIA, PERINEAL ABNORMALITY, AND GAPING INTROITUS AND MESH WAS IMPLANTED. IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT MESH REVISION/REMOVAL.

    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

    RESUBMISSION WITH THE CORRECT FILE NUMBER.IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL OOPHOROPEXY DUE TO SEVERE UTERINE LEIOMYOMA, AND CERVICAL DYSPLASIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    83346 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3102167

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention