BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3002341 · Received March 13, 2013

    Report

    Report Number
    2210968-2013-02418
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS AND BOWEL PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2007. 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
    104694 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention