BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 14758203 · Received June 21, 2022

    Report

    Report Number
    3013886523-2022-00286
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 13, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041474
    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 WAS RETURNED FOR EVALUATION: DHR - LOT 180555, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAKS, REFLUX 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 OVER DRAINAGE ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A PRESSURE ISSUE OF A HAKIM VALVE (ID 823114). PATIENT BECAME SYMPTOMATIC DUE TO OVERDRAINAGE. THE VALVE WAS IMPLANTED IN OCTOBER 2018. THE VALVE WAS EXPLANTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141370 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3112 10886704041474

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown