BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMASK

    MDR report key: 3761002 · Received April 11, 2014

    Report

    Report Number
    1417592-2014-00038
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER IS A RECEPTIONIST IN AN ER AND STATED THAT SHE DEVELOPED BLISTERING ON HER FACE AND SWELLING OF HER THROAT WHILE WEARING THE MASK. SHE WAS GIVEN A STEROID INJECTION AND PRESCRIBED A MEDROL PACK. SHE HAD PREVIOUSLY BEEN DIAGNOSED WITH A MULTIPLE ALLERGIES AND WAS SENT FOR ADDITIONAL TESTING. THUS FAR, SHE HAS ALSO BEEN DIAGNOSED WITH A CITRUS ALLERGY. WE HAVE HAD NO OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS DEVICE.

    Description of Event or Problem · 1

    WHILE WEARING THE MASK, THE END USER DEVELOPED BLISTERING ON HER FACE AND SWELLING OF HER THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220922 BIOMASK BSJ MEDLINE INDUSTRIES, INC. 13L2910

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other