BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DEVICE WITH PROLENE TAPE

    MDR report key: 9120306 · Received September 25, 2019

    Report

    Report Number
    2210968-2019-88127
    Event Type
    Injury
    Date Received
    September 25, 2019
    Report Date
    September 10, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT 881523 WAS UNAVAILABLE FOR REVIEW THEREFORE AN ASSESSMENT MEMO WAS ATTACHED FOR PRODUCT CODE 810041. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE IN 2002 AND THE MESH WAS IMPLANTED. THE PATIENT INDICATED THAT SHE HAS BEEN SUFFERING FOR TWENTY YEARS AND RECENTLY HAS HAD THE MESH REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909311 TVT DEVICE WITH PROLENE TAPE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 881523

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention