BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FACE MASK

    MDR report key: 24961948 · Received April 23, 2026

    Report

    Report Number
    9610691-2026-00009
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 23, 2026
    Manufacturer
    AMBU A/S
    Product Code
    BYG
    UDI-DI
    05707480023363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER SAMPLE NOR PICTURE WERE AVAILABLE; THEREFORE THE REPORTED FAILURE CANNOT BE VERIFIED. THE DISSATISFACTION IS MAINLY RELATED TO THE SHAPE AND CLINICAL USE OF THE MASK. NO MANUFACTURING DEFECTS WERE IDENTIFIED. AFTER REVIEWING THE DESIGN INPUT REQUIREMENTS OF REPORTED SAMPLE, THE REQUIREMENTS OF PRODUCT SEALING PROPERTY HAVE BEEN CONSIDERED AND VERIFIED IN THE DESIGN INPUT. TO ACCOMMODATE VARIABILITY IN FACIAL CHARACTERISTICS AND THE SEALING WITH THE SKIN ON THE PATIENT'S FACE, THE DISPOSABLE FACE MASK IS DESIGNED IN 6 SIZES AND THIN CUSHION WALL THICKNESS. IN THE IFU, IT HAS STATED ALL THE METHODS TO ENSURE THE SEALING PROPERTY WHEN USING DISPOSABLE FACE MASKS. THE CUSTOMER STATED THAT "TO KEEP THE MASK STABLE ON THE PATIENT'S FACE, THE INVOLVEMENT OF TWO OPERATORS IS OFTEN REQUIRED, WITH A NEGATIVE IMPACT ON THE PRACTICALITY AND EFFICIENCY OF THE PROCEDURE." IT SEEMS THE FACE MASK CAN ULTIMATELY ACHIEVE A SEAL WHEN SUFFICIENT FORCE IS APPLIED, BUT ONLY WITH THE ASSISTANCE OF TWO OPERATORS HOLDING IT IN PLACE THROUGHOUT THE PROCESS. THE REPORTED SAMPLE HAS A HOOK RING WHICH CAN CONNECT THE HEAD STRIPS TO FIX THE FACE MASK ON PATIENTS' FACE. IN THE IFU, IT ALSO HAS GUIDANCE OF USING HEAD STRIPS CONNECT TO HOOK RING. HENCE, THE USER'S PROBLEM CAN BE SOLVED IN THIS WAY. THE CUSTOMER USED TO WORK WITH KING MASKS, SINCE END 2025- BEGINNING 2026, THEY SWITCHED FROM AMBU KING MASKS TO DISPOSABLE FACE MASKS. THE KING MASKS FEATURE A THINNER, SOFTER CUSHION COMPARED TO DISPOSABLE FACE MASKS, WHICH MAY CONTRIBUTE TO THE WORSE USER EXPERIENCE WHEN SWITCHING TO THE LATTER. IN THIS COMPLAINT, PATIENT WAS INVOLVED BUT OUTCOME NOT AFFECTED. THIS IS THE SECOND COMPLAINT THAT CUSTOMER IS UNSATISFIED WITH THE DESIGN OF DISPOSABLE FACE MASK, AND THE OTHER COMPLAINT IS ALSO FROM THIS CUSTOMER. IT IS CONSIDERED AS ISOLATE CASE. NO CORRECTIVE ACTION IS NEEDED NOW, WE WILL KEEP MONITORING.

    Description of Event or Problem · 0

    IT WAS DIFFICULT TO VENTILATE THE PATIENT, AS THE MASK WAS NOT ADHERING CORRECTLY TO PATIENT'S FACE. PATIENT DESATURATED DURING ANESTHESIA INDUCTION. PATIENT HAD TO BE VENTILATED BY TWO PEOPLE SIMULTANEOUSLY AS THERE WAS SEVERE DESATURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460805 DISPOSABLE FACE MASK DISP MASK LARGE W/CHECK VALVE BYG AMBU A/S 1001242574 05707480023363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other