BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXAIR

    MDR report key: 10527450 · Received September 14, 2020

    Report

    Report Number
    10527450
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    May 14, 2020
    Report Date
    September 8, 2020
    Manufacturer
    SYNTECH DE BAJA CALIFORNIA, S DE RL DE CV
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CAPR FACE SHIELD WAS NOT STRETCHY ENOUGH TO ACCOMMODATE PULLING OVER HEAD INSIDE THE CAPR, DESPITE USING A SIZE LARGE. THIS EVENT DID NOT INVOLVE A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993926 MAXAIR GOWN, SURGICAL FYA SYNTECH DE BAJA CALIFORNIA, S DE RL DE CV

    Patients

    Seq Age Sex Outcome Treatment
    1