BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM PLUS DISPOSABLE ANESTHESIA FACE MASK

    MDR report key: 355555 · Received October 10, 2001

    Report

    Report Number
    1044265-2001-00036
    Event Type
    Malfunction
    Date Received
    October 10, 2001
    Date of Event
    September 7, 2001
    Report Date
    September 10, 2001
    Manufacturer
    PORTEX INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED DURING TESTING PRIOR TO USE THAT THE ANESTHESIA FACE MASK WAS BLOCKED, ALLEGEDLY WITH A WEB OF PLASTIC MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46044 PREMIUM PLUS DISPOSABLE ANESTHESIA FACE MASK ANESTHESIA FACE MASK BSJ PORTEX INC. NA BC0053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA