BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE MICRO

    MDR report key: 10275546 · Received July 15, 2020

    Report

    Report Number
    1226348-2019-00566
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    October 8, 2019
    Report Date
    November 4, 2019
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE, PRODUCT CODE 82-3112 WITH LOT 144184, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS- THE VALVE WAS VISUALLY INSPECTED: SOME BIOLOGICAL DEBRIS WAS NOTED INSIDE THE HOUSING. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSIONS, LEAKS, REFLUX AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED, AS THE TECHNICIAN WAS UNABLE TO CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER AT THE TIME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAKIM VALVE WAS NOT PROGRAMMABLE ANYMORE AND WAS REVISED.THE EVENT LEAD TO 30 MINUTES SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742019 PROG VALVE MICRO CHPV JXG RAYNHAM 144184

    Patients

    Seq Age Sex Outcome Treatment
    1