BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 14713217 · Received June 16, 2022

    Report

    Report Number
    3013886523-2022-00268
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    May 25, 2022
    Report Date
    September 7, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519805
    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 VALVE (ID 823832) WAS RETURNED FOR EVALUATION: REVIEW OF THE HISTORY DEVICE RECORDS FOR THE PRODUCT CODE 82-3832 WITH LOT 4739852, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS VISUALLY INSPECTED; THE SIPHON GUARD WAS RETURNED SEPARATE FROM THE VALVE, THE SILICONE HOUSING CUT/TORN ALONG THE SIPHON GUARD, MARKS WERE NOTED IN THE SIPHON GUARD. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, AS NOTED IN THE IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE ROOT CAUSE FOR THE MARKS IN THE SIPHON GUARD ARE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SIPHON GUARD.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS FOUND BROKEN THROUGH CT SCAN ONE WEEK AFTER IMPLANTATION. THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND CHANGED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208862 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823832 4739852 10381780519805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown