BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M AURA HEALTH CARE PARTICULATE RESPIRATOR AND MASK

    MDR report key: 7536640 · Received May 23, 2018

    Report

    Report Number
    7536640
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 17, 2018
    Manufacturer
    3M COMPANY
    Product Code
    MSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NURSE STATES THAT OCCASIONALLY SHE WILL OPEN A BRAND NEW N95 1870 MASK FOR EMPLOYEE FIT TESTING AND NOTICE THAT THE TOP FOLD OF THE MASK (WHICH WOULD GO OVER THE NOSE) IS BUNCHED UP, AS IT WILL NOT STRAIGHTEN COMPLETELY OUT, THUS PREVENTING A GOOD PROTECTIVE SEAL FIT. SHE NOTES THAT IT IS NOT ON ALL OF THEM JUST PERIODICALLY COMES ACROSS THEM. CONCERN THAT IF STAFF USE ONE OF THESE THAT IS BUNCHED UP DURING REAL PATIENT CARE THE SEAL WILL NOT BE COMPLETE AS THEY WERE FIT TESTED, THUS PUTTING THEM AT RISK FOR EXPOSURE. JUST A SAFETY CONCERN WE WOULD LIKE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378486 3M AURA HEALTH CARE PARTICULATE RESPIRATOR AND MASK RESPIRATOR, SURGICAL MSH 3M COMPANY C173481

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NOT APPLICABLE.