BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3024079 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02723
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING AND OTHER FOLLOWING MESH IMPLANTATION. THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2012 DUE TO INCONTINENCE AND PELVIC PAIN. IT WAS REPORTED THAT FOLLOWING MESH REMOVAL THE PATIENT¿S VAGINAL PAIN CHANGED, AND THE PATIENT NO LONGER HAS PULLING PAIN. BOTH SIDES OF THE PATIENT¿S CROTCH ARE NOW PAINFUL AND THE PAIN IS SHARP AND RADIATES DOWN THE LEGS ON THE INSIDE OF THE PATIENT¿S THIGHS BILATERALLY. THE PAIN IS DESCRIBED AS MUSCLE PAIN. THE PAIN IS AN EVERYDAY OCCURRENCE. SOMETIMES THE VAGINAL PAIN IS SHARP AND ACHY BUT IT CAN ALSO BE A SHOOTING PAIN THAT RADIATES DOWN THE LEGS. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). 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 SURGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. 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
    127044 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC. NA 1308842

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention