BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL W PRECHA

    MDR report key: 19034241 · Received April 3, 2024

    Report

    Report Number
    3013886523-2024-00094
    Event Type
    Injury
    Date Received
    April 3, 2024
    Report Date
    April 3, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519133
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823110) WAS NOT RETURNED FOR EVALUATION (THE PRODUCT HAS NOT BEEN EXPLANTED YET) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO THE VALVE NOT BEING CORRECTLY ATTACHED WHEN IMPLANTED. IF THE SAMPLE OR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAKIM VALVE (ID 823110) WAS IMPLANTED VIA VENTRICULAR PERITONEAL (VP) SHUNT IN (B)(6) 2023 FOR UNKNOWN REASON AND WITH UNKNOWN SETTING. IN (B)(6) 2024, THE DISTAL PART OF THE VALVE STARTED TO SWELL, AND LEAKAGE OF THE VALVE WAS CONFIRMED. THEREFORE, RE-OPERATION WAS PERFORMED. THE SHUNT WAS RE-CONNECTED TO THE VALVE. HOWEVER, IT STARTED TO SWELL AGAIN FROM BEGINNING OF (B)(6) 2024. THE PATIENT EXPERIENCED PAIN DUE TO SWELLING. THE PATIENT STATUS IS CURRENTLY ON FOLLOW-UP. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS A PLAN FOR REMOVING THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783371 PROG VALVE CLYNDRICAL W PRECHA CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10381780519133

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Male