BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M PARTICULATE RESPIRATOR AND SURGICAL MASK

    MDR report key: 1673955 · Received April 30, 2010

    Report

    Report Number
    2110898-2010-00044
    Event Type
    Other
    Date Received
    April 30, 2010
    Date of Event
    February 11, 2010
    Report Date
    April 29, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FXX
    PMA / PMN Number
    955382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THERE WERE NO MEDICAL INTERVENTION NEEDED AND NO PERMANENT DAMGE CAUSED TO THE USER, WE EVENTUALLY DECIDED TO REPORT THIS EVENT TO FDA. WE EVALUATED THE EVENT BY REVIEWING THE HISTORY OF THE PRODUCT ON THE MARKET. THE USER HAS DEVELOPED ALLERGIC REACTION TO MANY PRODUCTS IN PAST TWO YEARS. THIS IS A RARE CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN EMPLOYEE WITH A HISTORY OF RECENTLY ACQUIRED SENSITIVITIES WORE THE 1860 MASK 2 TIMES AND DEVELOPED ITCHING, REDNESS WITH SIGNIFICANT WELTS AND HER LIPS WERE NUMB AND TINGLING AFTER WEARING THE MASK FOR 20 MINUTES. REPORTEDLY, SYMPTOMS RESOLVED 1-2 HOURS AFTER THE MASK WAS REMOVED, HER LIPS WERE TINGLY THE NEXT DAY AND EVENTUALLY RESOLVED. IT WAS REPORTED, THERE WAS NO TREATMENT, SHE DISCONTINUED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M PARTICULATE RESPIRATOR AND SURGICAL MASK SURGICAL MASK FXX 3M HEALTH CARE 1860 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other