BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU BLUE SENSOR VLC

    MDR report key: 19229612 · Received May 2, 2024

    Report

    Report Number
    1220828-2024-00008
    Event Type
    Injury
    Date Received
    May 2, 2024
    Report Date
    May 31, 2024
    Manufacturer
    AMBU A/S
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR 1220828-2024-00008 REPORTED MAY 2, 2024: CURRENTLY, THERE IS VERY LIMITED INFORMATION ON THE REPORTED SKIN REACTION AND DETAILS ON HOSPITALIZATION. AMBU IS CURRENTLY TRYING TO FOLLOW UP WITH THE CUSTOMER TO RECEIVE MORE INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS FINALIZED. FOLLOW-UP #1 MDR 1220828-2024-00008 REPORTED MAY 31, 2024: WE WERE UNABLE TO VERIFY THE REPORTED FAILURE DUE TO LIMITED INFORMATION. THE AFFECTED SAMPLE WAS NOT RETURNED FOR INVESTIGATION, NOR DID WE RECEIVE INFORMATION ON THE LOT NUMBER. THEREFORE, NEITHER MANUFACTURING RECORDS NOR RETENTION SAMPLE COULD BE RETRIEVED. BLUE SENSOR VLC ELECTRODE WAS ASSESSED FOR CYTOTOXICITY, SENSITIZATION AND IRRITATION. THERE ARE 4 COMPONENTS IN DIRECT CONTACT WITH PATIENT'S SKIN ALL OF WHICH PASSED BIOLOGICAL TESTING TO ASSURE THAT THE MATERIALS ARE BIOCOMPATIBLE. WE CAN ONLY SUSPECT THAT AFFECTED PATIENT COULD BE SENSITIVE TO COMPONENTS IN THE ADHESIVE OR THE WET GEL OF THE ELECTRODE WHICH COULD LEAD TO SKIN REACTION. PATIENT'S ALLERGIC REACTION IS NOT CAUSED BY DEFECT IN THE ELECTRODE, BUT BECAUSE FEW PEOPLE MAY BE ALLERGIC OR SENSITIVE TO CERTAIN SUBSTANCES. PRODUCTION AND QUALITY CONTROL WERE MADE AWARE ON THIS INCIDENT VIA QUALITY ALERT AND WE WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS.

    Additional Manufacturer Narrative · 0

    CURRENTLY, THERE IS VERY LIMITED INFORMATION ON THE REPORTED SKIN REACTION AND DETAILS ON HOSPITALIZATION. AMBU IS CURRENTLY TRYING TO FOLLOW UP WITH THE CUSTOMER TO RECEIVE MORE INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS FINALIZED.

    Description of Event or Problem · 0

    INITIAL REPORT: PATIENT'S DAUGHTER REPORTED EXTREME SKIN REACTIONS LEADING TO HOSPITALISATION. FOLLOWUP REPORT: WE WERE UNABLE TO RETRIEVE MORE INFORMATION ON THE PATIENT'S CONDITION. THERE ARE NO PHOTOS AVAILABLE, NO DETAILS ON SKIN PREP NOR PATIENT OUTCOME ON BEING HOSPITALIZED.

    Description of Event or Problem · 0

    PATIENT'S DAUGHTER REPORTED EXTREME SKIN REACTIONS LEADING TO HOSPITALISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438420 AMBU BLUE SENSOR VLC AMBU BLUE SENSOR VLC DRX AMBU A/S VLC-00-S/4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization