BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTIVE MASK WITH PM2.5 FILTER

    MDR report key: 10507631 · Received September 8, 2020

    Report

    Report Number
    MW5096493
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 4, 2020
    Manufacturer
    VIDA
    Product Code
    JRL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDICATION REQUIRED; I PURCHASED A COTTON PROTECTIVE MASK WITH MULTILAYER 2.5PM FILTER (SKU: 201000000032) FROM VIDA. AFTER WEARING THE MASK WITH THE FILTER FOR ABOUT 3 HOURS ON (B)(6) 2020, I STARTED TO HAVE SINUS CONGESTION. I REMOVED THE MASK, BUT THE CONGESTION WORSENED, I HAD SEVERE SINUS PAIN, SNEEZING, AND TIGHTNESS IN MY CHEST. THE PAIN, CONGESTION, AND SNEEZING CONTINUED THROUGH THE NIGHT AND INTO THE MORNING OF (B)(6) 2020. THE PROBLEMS WERE MOSTLY RELIEVED WITH AN OVER- THE- COUNTER DECONGESTANT, ANTI-INFLAMMATORY, AND ANTIHISTAMINE. I ALSO USED A PRESCRIPTION ASTHMA INHALER TO RELIEVE THE CHEST WHEEZING. I DID NOTHING DIFFERENT DURING MY DAILY ROUTINE OVER THAT TIME; I DID NOT EAT ANY NEW FOODS, DID NOT TAKE ANY NEW MEDICATIONS, AND WAS NOT EXPOSED TO ANY OTHER CHEMICALS DURING THAT TIME. THIS LEADS ME TO THINK THAT THE FILTER IN THE MASK MAY BE THE CAUSE OF MY ADVERSE REACTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964847 PROTECTIVE MASK WITH PM2.5 FILTER UNIT, FILTER, MEMBRANE JRL VIDA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other