BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 17172718 · Received June 21, 2023

    Report

    Report Number
    3013886523-2023-00192
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    June 1, 2023
    Report Date
    August 10, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3832 WITH LOT 6483275, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS: THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAKS, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE- NO ROOT CAUSE COULD BE DETERMINED FOR THE FAILURE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM. AS SEEN IN THE INVESTIGATION REPORT NO OCCLUSION ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2023. THREE DAYS LATER, THE PHYSICIAN FOUND THAT THERE WAS SUBCUTANEOUS HYDROPS AND THE VALVE WAS OCCLUDED. DUE TO OCCLUSION THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2023. THE PATIENT IS NOW STABLE.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822235 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 6483275 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown