BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK

    MDR report key: 13186164 · Received January 7, 2022

    Report

    Report Number
    2110898-2022-00002
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    June 16, 2020
    Report Date
    January 6, 2022
    Manufacturer
    3M HEALTH CARE
    Product Code
    FXX
    UDI-DI
    70070612364
    PMA / PMN Number
    K955382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION IS NOT AVAILABLE. LOT NUMBER PROVIDED IS NOT A 3M LOT NUMBER. EXPIRATION DATE IS NOT AVAILABLE WITHOUT A LOT NUMBER. MANUFACTURE DATE IS NOT AVAILABLE WITHOUT A LOT NUMBER. THE LOT NUMBER PROVIDED IN THE COMPLAINT IS NOT A VALID 3M¿ LOT NUMBER FOR THE 1860 OR 1860S MEDICAL DISPOSABLE RESPIRATORS. 3M¿ IS UNABLE TO CHECK PRODUCTION RECORDS/RETAINS WITHOUT A LOT NUMBER. 3M¿ TAKES VERY SERIOUSLY THE SAFETY OF OUR PRODUCTS AND WE REVIEW THE POSSIBLE CAUSES OF ALL COMPLAINTS. SINCE THE INTENDED USE OF THIS PRODUCT INCLUDES SKIN CONTACT, THE MATERIALS USED IN THE RESPIRATOR HAVE BEEN EVALUATED BY TOXICOLOGISTS IN THE 3M MEDICAL DEPARTMENT PAYING PARTICULAR ATTENTION TO BASE CHEMICALS AND RAW MATERIALS WHICH MIGHT POSE RISK FOR DERMAL IRRITATION, ALLERGY, OR TOXICITY. BASED ON THESE REVIEWS, NO RISK FOR ADVERSE HEALTH EFFECTS IS EXPECTED WHEN THE RESPIRATOR IS USED AS INTENDED AND FOLLOWING INSTRUCTIONS FOR USE. 3M WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED DRY EYES, EMOTIONAL CHANGES, CORNEAL CLOUDING, HYPERSENSITIVITY/ALLERGIC REACTION, PAIN, RASH, UVEITIS, MALAISE, WEIGHT CHANGES, CHEMICAL EXPOSURE, SYNCOPE, UNSPECIFIED RESPIRATORY PROBLEM AND EYE/VISION PROBLEM AFTER WEARING THE 3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1860, N95 AT WORK. THE CUSTOMER ALLEGES A STRONG ODOR FROM THE MASK. AFTER WEARING THE MASK SHE OBSERVED A SKIN REACTION, SEVERE CHEMICAL ALLERGY AND REOCCURRING EYE INJURIES. NO MEDICAL INTERVENTIONS WERE REPORTED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853754 3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK TAPE AND BANDAGE, ADHESIVE FXX 3M HEALTH CARE N/A UNKNOWN 70070612364

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability| O