BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICORGARD II FILTER

    MDR report key: 22326296 · Received June 25, 2025

    Report

    Report Number
    9615102-2025-00173
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 2, 2025
    Report Date
    June 25, 2025
    Manufacturer
    JAEGER MEDICAL GMBH
    Product Code
    BYP
    UDI-DI
    04250892907383
    PMA / PMN Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED, AND NO ADDITIONAL INFORMATION REGARDING THE PRODUCT OR THE INCIDENT HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE FURTHER DETAILS ARE AVAILABLE AND AN INVESTIGATION INTO THE INCIDENT CAN BE CONDUCTED. THE RISK OF AN ALLERGIC REACTION IS ADDRESSED WITHIN THE RISK MANAGEMENT DOCUMENTATION AND HAS BEEN ASSESSED AS AN ACCEPTABLE HEALTH RISK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CUSTOMER HAS CONCERNS ABOUT AN ALLERGIC REACTION OF A PATIENT IN ASSOCIATION WITH THE BLUE TIP OF THE MICROGARD FILTER. DESPITE REMINDERS, THE CUSTOMER DID NOT PROVIDED FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997659 MICORGARD II FILTER BREATHING MOUTHPIECE, SINGLE-USE BYP JAEGER MEDICAL GMBH MICORGARD II FILTER 04250892907383

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown