BEUDAMED
    FDA Adverse Event Other Summary report: N

    1838R GLOBAL FILTRON SURGICAL MASK

    MDR report key: 2582487 · Received February 1, 2010

    Report

    Report Number
    2110898-2010-00006
    Event Type
    Other
    Date Received
    February 1, 2010
    Date of Event
    January 5, 2010
    Report Date
    February 1, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FXX
    PMA / PMN Number
    K940707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT SHE HAS EXPERIENCED IRRITATION IN THE PAST DUE TO THE 1818 MASK AND EXPERIENCED SOME CLAUSTROPHOBIC FEELINGS. 3M IS SENDING THE CUSTOMER OTHER MODELS, THE DUCKBILL AND MOLDED MASKS, TO TRY. BASED ON THE INFO REPORTED, 3M WAS NOT PROVIDED ENOUGH INFO TO DRAW A CONCLUSION IF OTHER FACTORS CONTRIBUTED TO THE EVENTS. 3M WILL PROVIDE AN UPDATED REPORT WHEN FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DEVELOPING A SEVERE REACTION TO THE 1838R MASK. SHE REPORTED THAT SHE DEVELOPED A REACTION ON HER CHEEKS, ACROSS THE BRIDGE OF HER NOSE, ON HER TEMPLES, CHIN AND BOTTOM LIP. HER DERMATOLOGIST TREATED HER WITH 12 STEROID INJECTIONS IN THE FACE AND A TOPICAL 1% HYDROCORTISONE AND CLINDAMYCIN CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1838R GLOBAL FILTRON SURGICAL MASK MASK FXX 3M HEALTH CARE 1838R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other