BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

    MDR report key: 4792437 · Received May 15, 2015

    Report

    Report Number
    2110898-2015-00020
    Event Type
    Injury
    Date Received
    May 15, 2015
    Manufacturer
    3M HEALTH CARE
    Product Code
    MSH
    PMA / PMN Number
    K063023
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDERGOING AN EVAL BUT HAS NOT YET BEEN COMPLETED. THE EVAL OF THIS MASK HAS NOT BEEN COMPLETED BUT DEVICE HAS BEEN RETURNED FOR EVAL. CONTACT AREAS INNER WEB AND HEADBAND WERE SUBJECT TO HUMAN REPEAT INSULT PATCH TESTING (HPIRT) AND INDICATED NO CONTACT FOR SENSITIZATION BASED ON TEST SUBJECTS. USER INDICATED THEY USE A PORTACOUNT SYSTEM FOR RESPIRATOR FIT TESTING. HE DOES NOT USE THE METHOD OF EXPOSURE TO SACCHARIN.

    Description of Event or Problem · 1

    A MALE WHO WAS CONDUCTING RESPIRATOR FIT TESTING AT HIS MED CTR DONNED A 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, CATALOG NUMBER 1870 ON (B)(6) 2015. WITHIN 3 MINUTES HE ALLEGED HIS FACE BURNED WHERE THE 3M SURGICAL MASK TOUCHED HIS SKIN. HE ALLEGED HIS EYES WATERED AND BURNED, HIS THROAT BECAME SCRATCHY, HE BEGAN TO SNEEZE AND HAD SHORTNESS OF BREATH. HE WENT TO THE EMERGENCY ROOM WHERE HE WAS GIVEN AN EPINEPHRINE AND INTRAVENOUS BENADRYL (DIPHENHYDRAMINE). HE WENT TO SEE AN ALLERGIST THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318004 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK RESPIRATOR, SURGICAL (CFR878-4040) MSH 3M HEALTH CARE NA C140221

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention NONE SPECIFIED