BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DEVICE WITH PROLENE TAPE

    MDR report key: 9271991 · Received November 4, 2019

    Report

    Report Number
    2210968-2019-89442
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    October 1, 2005
    Report Date
    October 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT 1080742 WAS UNAVAILABLE FOR REVIEW THEREFORE AN ASSESSMENT MEMO WAS AVAILABLE 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 GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND THE MESH WAS IMPLANTED. POST-OP, THE PATIENT EXPERIENCED SYMPTOMS OF URINARY TRACT INFECTION, DIFFICULTY URINATING, PAIN OF PELVIC AREA, HIPS AND LEGS, DIFFICULTY WALKING AND CLIMBING STAIRS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070200 TVT DEVICE WITH PROLENE TAPE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1080742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention