BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3202777 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11968
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL ON (B)(6) 2009 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301051 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention