BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2032027 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00361
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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). ON (B)(6) 2009, THE PATIENT UNDERWENT A RETROPUBIC EXCISION OF A GROWTH, CYSTOSCOPY X2, AND A BURCH PROCEDURE. AT THE TIME, A FIVE CM BENIGN GROWTH WAS REMOVED. (B)(4) BENIGN GROWTH.

    Additional Manufacturer Narrative · 1

    CONCOMITANTLY ON (B)(6) 2006, THE PATIENT UNDERWENT TREATMENT FOR A CYSTOCELE. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-02399. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/28/2011 (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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED DUE TO CYSTOCELE WITH COMPONENT OF URETHRAL DIVERTICULUM AND RECTOCELE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT URETHRAL COLLAGEN INJECTION AND CYSTOSCOPY ON (B)(6) 2007 DUE TO RECURRENT SUI. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT PELVIC ORGAN PROLAPSE AND STRESS INCONTINENCE ON (B)(6) 2006 AND A SLING WAS IMPLANTED INTO THE PATIENT. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL,POLYMERIC OTN ETHICON SARL A JOHNSON & JOHNSON COMPANY NA 1349340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention