BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3010844 · Received March 19, 2013

    Report

    Report Number
    2210968-2013-02576
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED VAGINAL INFECTIONS, PAIN DURING URINATION AND INTERCOURSE, PELVIC PAIN AND RECURRENCE OF INCONTINENCE. (B)(4).

    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

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT VAGINAL INFECTIONS, PAIN DURING URINATION AND INTERCOURSE, AND RECURRENCE OF INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF A HYSTERECTOMY PERFORMED DURING MESH IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, URINARY TRACT INFECTIONS 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
    113340 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention