BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL W PRECHA

    MDR report key: 16022840 · Received December 21, 2022

    Report

    Report Number
    3013886523-2022-00580
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 10, 2022
    Report Date
    February 15, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519133
    PMA / PMN Number
    K122118
    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 WAS RETURNED FOR EVALUATION: DHR - LOT 5822407, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAKS AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. 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 AT THE TIME OF INVESTIGATION NO FUNCTIONAL ISSUES WERE NOTED WITH THE VALVE.

    Description of Event or Problem · 0

    2 OF 2 REPORTS (SAME PATIENT, DIFFERENT VALVES). OTHER MFG REPORT NUMBER: 3013886523-2022-00579. A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2022 IN A 58 YEAR OLD MALE PATIENT. IT DID NOT FUNCTION PROPERLY AND WAS REPLACED ON (B)(6) 2022 WITH A NEW VALVE (ID 823110). THE SECOND VALVE PRESENTED WITH THE SAME FAILURE AND WAS EXPLANTED ON (B)(6) 2022. IT SEEMS THAT THERE WERE SOME DEBRIS IN THE VALVES. CONSEQUENCES FOR THE PATIENT: DROP IN CONSCIOUSNESS, LONGER HOSPITAL STAY. THE PATIENT STATUS IS: RECOVERED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023436 PROG VALVE CLYNDRICAL W PRECHA CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 823110 5822407 10381780519133

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male