BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 22017976 · Received May 14, 2025

    Report

    Report Number
    3013886523-2025-00106
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    May 6, 2025
    Report Date
    August 21, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519805
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE INITIAL REPORT WAS SENT WITH AN INCORRECT REGULATORY AWARENESS DATE OF 4/26/2025. THE CORRECT REGULATORY AWARENESS DATE IS 5/6/2025. UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823832) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, THE PROBABLE ROOT CAUSE FOR THE "INFECTION" ISSUE REPORTED BY THE CUSTOMER COULD BE LINKED TO THE PATIENT AND HOSPITAL SURROUNDINGS OR COULD BE DUE TO INADEQUATE DESIGN CHOICE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    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

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00107. A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE WERE IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD FEVER AND WAS TESTED WITH CSF (CEREBRO-SPINAL FLUID) POSITIVE. THE PATIENT RECEIVED ANTI-INFECTIVE THERAPY. ON (B)(6) 2025, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND IMPLANTED A NEW HAKIM VALVE (ID 823832) AND A NEW BACTISEAL CATHETER (ID 823072). THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090172 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6874343 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention