BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTA-GARD SURGICAL MASK W/ FOG FREE VAP

    MDR report key: 2878259 · Received December 18, 2012

    Report

    Report Number
    1423537-2012-00046
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED; WITHOUT THE LOT NUMBER, WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD TO DETERMINE IF ANY DEVIATIONS TOOK PLACE DURING THE MANUFACTURING PROCESS OF THIS DEVICE. NO SAMPLE WAS PROVIDED FOR EVALUATION. WITHOUT THE SAMPLE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. DURING THE PRODUCT DEVELOPMENT PHASE, ALL MATERIALS USED FOR THE MASK WERE EVALUATED FOR BIOCOMPATIBILITY. THE TESTING WAS PERFORMED IN ACCORDANCE WITH INTERNATIONAL STANDARD ISO 10993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. ONLY MATERIALS THAT SUCCESSFULLY COMPLETE THESE TESTS CAN BE COMMERCIALIZED. THIS MASK IS ENGINEERED WITHOUT DYES OR OTHER POTENTIALLY IRRITATING MATERIALS. NO CORRECTIVE ACTION WILL BE TAKEN. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    SURGICAL TECH DEVELOPED RASH/HIVES/SWELLING OF FACE AND NECK APPARENTLY AFTER USING THIS MASK. HE WENT TO URGENT CARE AND WAS GIVEN A STEROID FOR DERMATITIS. HE ALSO MISSED TWO WEEKS OF WORK AND WAS ON WORKER'S COMP. HE RETURNED TO LIGHT DUTY. UPON HIS RETURN HE SWITCHED BACK TO HIS ORIGINAL MASK (NOT A CARDINAL HEALTH MASK), BUT THEN REACTED TO IT ALSO. HE HAS BEEN REFERRED FOR ALLERGY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTA-GARD SURGICAL MASK W/ FOG FREE VAP MASK, SURGICAL FXX CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other