BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M PARTICULATE RESPIRATOR AND SURGICAL MASK

    MDR report key: 3021286 · Received March 22, 2013

    Report

    Report Number
    3021286
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 22, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SEVERAL CLINICIANS NOTED THAT WHEN THEY TRIED TO PLACE THEIR FITTED N95 SURGICAL MASKS THEY FOUND THAT THE MASK HAD A LOOSE FIT AROUND THE OUTER PERIMETER AND NOSE SECTION OF THE MASK. ALL CLINICIANS HAD BEEN SPECIALLY FITTED FOR THE N95 MASK. CENTRAL SUPPLY RECEIVED COMPLAINTS FROM SEVERAL USERS OF THE MASK. MANUFACTURER NOTIFIED AND CONFIRMED THAT THE NEWEST LOT NUMBER WAS INCORRECTLY SIZED AND OUT OF SPECIFICATION. ALL MASKS WITH AFFECTED LOT NUMBER REMOVED FROM INVENTORY. THESE MASKS ARE USED IN HIGH RISK AREAS AND ISOLATION ROOMS.======================MANUFACTURER RESPONSE FOR HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, N95 (PER SITE REPORTER).======================MANUFACTURER REMOVED AFFECTED LOT NUMBER AND WILL FOLLOW UP WITH OUR MATERIALS GROUP.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ACCESS TO ISOLATION ROOMS AND STERILE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119944 3M PARTICULATE RESPIRATOR AND SURGICAL MASK RESPIRATOR,SURGICAL FXX 3M HEALTH CARE 1860 B13028

    Patients

    Seq Age Sex Outcome Treatment
    1 *