BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 15121622 · Received July 27, 2022

    Report

    Report Number
    MW5111159
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 26, 2022
    Manufacturer
    ETHICON, JOHNSON & JOHNSON SURGICAL TECHNOLOGIES / ETHICON ENDO-SURGERY, INC.
    Product Code
    QJN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LINX DEVICE SEEMS TO BE OPENED POSTERIORLY WITH DISLODGEMENT OF THE CONNECTIONS BETWEEN BEADS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427042 THE LINX REFLUX MANAGEMENT SYSTEM LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING QJN ETHICON, JOHNSON & JOHNSON SURGICAL TECHNOLOGIES / ETHICON ENDO-SURGERY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female