BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 8662170 · Received June 3, 2019

    Report

    Report Number
    2210968-2019-82217
    Event Type
    Injury
    Date Received
    June 3, 2019
    Report Date
    May 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2006. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2008. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2010. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2011. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2006, (B)(6) 2008, (B)(6) 2010, (B)(6) 2011, AND (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456530 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention