BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20472665 · Received October 17, 2024

    Report

    Report Number
    3013886523-2024-00321
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    August 23, 2024
    Report Date
    February 21, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519232
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024. ALL BROKEN PARTS WERE RECOVERED. THERE IS NO INFORMATION AVAILABLE ON WHETHER THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS DUE TO THE DEVICE ISSUE. IT IS UNKNOWN IF AN X-RAY WAS TAKEN TO ASSURE THAT NO BROKEN PARTS LEFT IN THE PATIENT.

    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 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- THE PRODUCT CODE 82-3162 WITH LOT 6987042, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 40 MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE SIPHON GUARD WAS BROKEN. CUT AND TEAR MARK WERE NOTED ON THE SIPHON GUARD AND HOUSING. THE COMPLAINT WAS CONFIRMED ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE VALVE OR ATYPICAL HANDLING, AS NOTED IN THE SURGICAL PROCEDURE PRECAUTIONS SECTION IN INSTRUCTION FOR USE (IFU), SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED ON (B)(6) 2024. AFTER THE PROCEDURE, THE HYDROCEPHALUS OF THE PATIENT DIDN'T IMPROVE. ON (B)(6) 2024, THE PHYSICIAN CONDUCTED THE REVISION PROCEDURE AND FOUND THAT THE VALVE WAS BROKEN. THEREFORE, THE VALVE WAS REMOVED AND REPLACED. AFTER THE PROCEDURE, THE PATIENT FELT BETTER AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287243 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6987042 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention