BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNAREX EAR LOOP PROCEDURE MASK

    MDR report key: 444717 · Received January 22, 2003

    Report

    Report Number
    2431014-2003-09001
    Event Type
    Other
    Date Received
    January 22, 2003
    Date of Event
    September 13, 2002
    Report Date
    January 15, 2003
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE NURSES USING THE EAR LOOP MASKS REPORTED BLOTCHES ON THEIR FACES. TWO WERE TAKEN TO THE E.R. AND ONE OF THE TWO WAS GIVEN A STEROID SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAREX EAR LOOP PROCEDURE MASK PLEATED PROTECTIVE FACE MASK FXX DYNAREX CORPORATION EAR LOOP PROCEDURE MASK 14929

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other