BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SENSITIVE EARLOOP MASK

    MDR report key: 14885063 · Received July 1, 2022

    Report

    Report Number
    1319130-2022-00002
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 3, 2022
    Report Date
    July 1, 2022
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    FXX
    UDI-DI
    10732224120017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CROSSTEX SPSMEDICAL HAS CONTACTED THE CUSTOMER REQUESTING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE STATUS OF THE EMPLOYEE. TO DATE, WE HAVE NOT RECEIVED ADDITIONAL INFORMATION. THE ULTRA SENSITIVE EARLOOP MASK IS MADE WITH A HYPOALLERGENIC CELLULOSE INNER LAYER AND IS LATEX FREE. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE RESULTS FROM THE PATCH TEST FOUND THAT THE EMPLOYEE IS LATEX SENSITIVE AND ALLERGIC TO 2 RUBBER ACCELERATORS (THIURAM MIX AND BLACK RUBBER MIX). TESTING CONFIRMED THAT THERE ARE NO RUBBER ACCELERATORS OR LATEX IN THE ULTRA SENSITIVE MASK COMPONENTS, AS CONFIRMED BY THE SUPPLIERS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WITHIN 3 WEEKS OF USING THE ULTRA SENSITIVE EARLOOP MASK AN EMPLOYEE'S FACE WAS BURNING AND HAD BLISTERS. THE EMPLOYEE WAS TREATED WITH PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205977 ULTRA SENSITIVE EARLOOP MASK SURGICAL MASK FXX SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. GCFCXS 20191021, 20200124 10732224120017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown