BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 17819472 · Received September 26, 2023

    Report

    Report Number
    3013886523-2023-00336
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 18, 2023
    Report Date
    November 22, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041481
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823113) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- LOT 4072022, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED AND NO DEFECTS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 100MMH2O. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. THE CATHETER ENDS WERE VISUALLY INSPECTED, AND SHOW SIGNS OF BEING TORN APART. ROOT CAUSE ANALYSIS- THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS PROBABLY IS PROBABLY DUE TO THE PATIENT'S GROWTH AS NOTED IN THE COMPLAINT, ALSO AS NOTED IN THE IFU SILICONE HAS A LOW TEAR/CUT RESISTANCE.

    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.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ABOUT 3 YEARS AGO WITH AN UNKNOWN SETTING. THE PATIENT'S GROWTH WAS TAKEN INTO ACCOUNT; THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2023. WHEN IT WAS REMOVED, THE DISTAL PART OF THE VALVE WAS TORN DUE TO THE PULL OF THE CONNECTIVE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973609 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown