KN95 MASK
Received Dec 3, 2021 · Event occurred Jun 16, 2020
Report MW5105772 · MDR key 12933578
Device
Product problems
- Device Emits Odor
- Product Quality Problem
- Improper or Incorrect Procedure or Method
Patient
52 YR · Female
- Dry Eye(s)
- Emotional Changes
- Corneal Clouding/Hazing
- Hypersensitivity/Allergic reaction
- Pain
- Rash
- Uveitis
- Malaise
- Chemical Exposure
- Weight Changes
- Syncope/Fainting
- Unspecified Respiratory Problem
- Unspecified Eye / Vision Problem
- Dry Eye(s)
- Emotional Changes
- Corneal Clouding/Hazing
- Hypersensitivity/Allergic reaction
- Pain
- Rash
- Uveitis
- Malaise
- Chemical Exposure
- Weight Changes
- Syncope/Fainting
- Unspecified Respiratory Problem
- Unspecified Eye / Vision Problem
Narrative
Description of Event or Problem
PATIENT CALLED TO REPORT A SERIOUS ADVERSE EVENT INVOLVING N95 MASKS MANUFACTURED BY 3M. PATIENT STATED SHE HAS WORKED IN THE DENTAL INDUSTRY SINCE 1995 AND HAS WORN MANY DIFFERENT MASKS AND PRODUCTS AS A DENTAL HYGIENIST AND DENTAL ASSISTANT FOR ALMOST 30 YEARS AND NEVER EXPERIENCED ANY ISSUES. PATIENT STATED WHEN SHE RETURNED TO WORK AFTER THE COVID-19 SHUTDOWN ON (B)(6) 2020, SHE WAS GIVEN THESE 3M KN95 MASKS TO WEAR. PATIENT STATED SHE WAS INSTRUCTED BY HER EMPLOYER TO WEAR THE SAME MASK AND RE-USE IT FOR A MONTH. PATIENT STATED SHE WORE THESE MASKS BETWEEN (B)(6) 2020 AND (B)(6) 2020 EVERYDAY, ALL DAY WHILE WORKING AND SAID THE MASKS SMELLED STRONGLY LIKE PAINT THINNER. SOON AFTER WEARING THE MASKS, THE PATIENT STATED SHE STARTED NOTICING A SKIN REACTION. PATIENT SAID SHE STARTED EXPERIENCING MANY OTHER SYMPTOMS SUCH AS: SEVERE CHEMICAL ALLERGIES TO EVERYTHING, REACTIONS TO PRODUCTS SHE'S USED FOR YEARS, MOUTH BURNING, WEIGHT LOSS, AFFECTED HER VOICE, AND PASSED OUT WHILE DRIVING. PATIENT STATED SHE NOW SUFFERS FROM FIVE PERMANENT, REOCCURRING EYE INJURIES INCLUDING ANTERIOR UVEITIS, PERMANENT DRY EYE SYNDROME, AND PERIPHERAL OPACITY OF CORNEA. PATIENT STATED SHE EXPERIENCES SHORTNESS OF BREATH, DIFFICULTY BREATHING, EYEBALL SWELLING, PAIN, SEVERE BREAKOUTS, AND WAS UNABLE TO GET OUT OF BED FOR 3 MONTHS. PATIENT STATED THE USE OF THESE MASKS HAS DESTROYED HER LIFE AND SAID SHE FEELS SHE'S BEING PUSHED TO RESIGN FROM HER JOB. PATIENT STATED THE MASKS ARE ILLEGAL MASKS PROVIDED BY 3M AND STATED SHE DOES NOT TRUST 3M AND WILL NOT SEND BACK THE REMAINING MASKS SHE HAS IN HER POSSESSION. PATIENT STATED SHE PLANS TO GET A LAWYER AND FIGHT THIS AND SAID SHE HAS FELT DISREGARDED BY HER WORK AND 3M. PATIENT STATED THAT EVEN WRAPPED IN PLASTIC SHE CAN SMELL THE MASKS AND THEY HAVE A STRONG CHEMICAL SMELL LIKE PAINT THINNER. PATIENT STATED THAT DUE TO THE SEVERE CHEMICAL ALLERGIES SHE'S DEVELOPED SHE IS UNABLE TO WORK, CAN BARELY LEAVE HER HOME AND MAY LOSE HER HOUSE.