BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3121510 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05681
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 29, 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

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MENORRHAGIA. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, URINARY PROBLEMS, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2010 DUE TO EXPOSED MESH, PELVIC PAIN, DYSPAREUNIA, PAIN AND DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A DIAGNOSTIC HYSTEROSCOPY AND NOVASURE ENDOMETRIAL ABLATION CYSTOSCOPY DUE TO MENORRHAGIA. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2010.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF 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
    224513 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3135652

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention