BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3053345 · Received April 11, 2013

    Report

    Report Number
    2210968-2013-03742
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005 CONCURRENTLY WITH ANTERIOR COLPORRHAPHY, MID-URETHRAL SLING, AND CYSTOSCOPY IN ORDER TO TREAT GENUINE STRESS URINARY INCONTINENCE, URGENCY AND FREQUENCY SYNDROME, MIXED INCONTINENCE, URETHRAL RIGIDITY, AND 2ND DEGREE CYSTOCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2006, APPROXIMATELY 2010, APPROXIMATELY (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT UNDERWENT URETHROLYSIS ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT UNDERWENT A BACK IMPLANT IN 2008, A BLADDER SUSPENSION SURGERY IN 2009, AND A LAPAROSCOPIC SURGERY IN 2010. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. 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
    154949 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1324056

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention