BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

    MDR report key: 7379762 · Received March 28, 2018

    Report

    Report Number
    2110898-2018-00037
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    March 19, 2018
    Report Date
    March 28, 2018
    Manufacturer
    3M HEALTH CARE
    Product Code
    MSH
    PMA / PMN Number
    K955382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED- WITHOUT THE LOT NUMBER, WE CAN NOT DETERMINE THE UDI, EXPIRATION DATE AND MANUFACTURING DATE. NO SAMPLE WAS RETURNED FOR ANALYSIS. THE 3M SURGICAL RESPIRATOR IS NOT MADE WITH NATURAL RUBBER LATEX. THE USER FACILITY IS INVESTIGATING TO CONFIRM THE DIAGNOSIS AND OTHER POTENTIAL SOURCES OF LATEX THAT THE PATIENT MAY HAVE BEEN EXPOSED TO. END OF REPORT.

    Description of Event or Problem · 1

    A FEMALE EMPLOYEE EXPERIENCED AN ANAPHYLACTIC REACTION AND ALLEGED THAT IT COULD BE DUE TO A 3M SURGICAL RESPIRATOR. NO INFORMATION REGARDING MEDICAL INTERVENTION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221658 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK SURGICAL RESPIRATOR MSH 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening