BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3233988 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13697
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE 67, 92: 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, BLEEDING AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL MESH EXCISION ON (B)(6) 2007 AND (B)(6) 2008 AND UNDERWENT MESH REMOVAL ON 06/20/2008 DUE TO EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND AMS MINARC WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    335070 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK 2980748

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention