BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3020543 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02778
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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). 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.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED NERVE DAMAGE, MUSCLE SPASMS CAUSING SEVERE CONSTANT PAIN, SEVERE GROIN PAIN, STABBING PAIN IN RIGHT PELVIC AREA EXTENDING TO LOWER BACK, VAGINAL PAIN, PAINFUL INTERCOURSE AND URINARY INCONTINENCE. THE PATIENT UNDERWENT AN EXPLORATORY PELVIC EXAM IN 2008. THE PATIENT UNDERWENT EXPLORATORY PELVIC SURGERY, CONCURRENTLY WITH EXCISION OF RIGHT OVARY AND CYST IN 2008. THE PATIENT UNDERWENT DILATION AND CURETTAGE IN 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124483 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2998049

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention