BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM PLUS DISPOSABLE ANESTHESIA FACE MASK

    MDR report key: 342424 · Received July 13, 2001

    Report

    Report Number
    1044265-2001-00026
    Event Type
    Malfunction
    Date Received
    July 13, 2001
    Date of Event
    June 1, 2001
    Report Date
    June 14, 2001
    Manufacturer
    SIMS PORTEX INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES THAT THE ANESTHESIA FACE MASK WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31807 PREMIUM PLUS DISPOSABLE ANESTHESIA FACE MASK ANESTHESIA FACE MASK BSJ SIMS PORTEX INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO