BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX

    MDR report key: 10733232 · Received October 23, 2020

    Report

    Report Number
    MW5097436
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 21, 2020
    Manufacturer
    JOHNSON & JOHNSON /ETHICON ENDO-SURGERY, INC.
    Product Code
    QJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TORAX ETHICON (WAS TORAX) LINX ANTI REFLUX DEVICE IMPLANTED (B)(6) 2016. RECEIVED RECALL NOTICE 9/2018. GERD RETURNED (B)(6) 2020. LINX IMPLANT CONFIRMED SEPARATED (B)(6) 2020 (BARIUM SWALLOW). HAVE CONTACTED ETHICON BUT NO REPLY YET. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195961 LINX LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING QJN JOHNSON & JOHNSON /ETHICON ENDO-SURGERY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention