BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3032633 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03131
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    July 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT MIXED URINARY INCONTINENCE, FREQUENCY, AND URGENCY AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT LATER UNDERWENT THE ADDITIONAL PROCEDURES OF CYSTOSCOPIC URETHRAL COAPTITE INJECTION ((B)(6) 2012), IMPLANTATION OF TEMPORARY BLADDER STIMULATOR ((B)(6) 2012), AND IMPLANTATION OF PERMANENT BLADDER STIMULATOR ((B)(6) 2013).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6)2017.

    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 AN OBTURATOR SLING PROCEDURE (B)(6) 2010. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136480 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC. NA 3398079

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention