N95 RESPIRATOR - FISH STYLE HEADBAND
Received Jan 31, 2023 · Event occurred Jan 24, 2023
Report MW5114616 · MDR key 16278979
Device
Generic name
Respirator, Surgical
Manufacturer
Bnx Converting, LlcModel number
F95BCatalog number
BN-N95-F95B-10PP
Lot number
F223817
Product problems
- Patient-Device Incompatibility
Patient
46 YR · Female
- Erythema
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Peeling
- Burning Sensation
- Skin Inflammation/ Irritation
- Nodule
- Erythema
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Peeling
- Burning Sensation
- Skin Inflammation/ Irritation
- Nodule
Narrative
Description of Event or Problem
THIS IS REGARDING AN N95 FACE MASK FROM MANUFACTURER BNX. I TRIED THE MASK ON, AND WITHIN A FEW MINUTES DEVELOPED REDNESS, BURNING, AND ITCHING AROUND MY NOSE, CHEEKS, AND CHIN WHERE THE MASK HAD MADE CONTACT. OVER THE NEXT 12 HOURS MY ENTIRE FACE ERUPTED IN BUMPS, REDNESS, ITCHING, AND BURNING. WITHIN 72 HOURS OTHER PATCHES OF IRRITATION DEVELOPED ELSEWHERE ON MY BODY (WRISTS, NECK, AND EARS). IN REVIEWING WITH A DERMATOLOGIST, THEY ADVISED THIS IS MOST LIKELY AN ALLERGIC REACTION OR CHEMICAL BURN. I HAVE PREVIOUSLY HAD A SENSITIVITY TO NICKEL, AND THE REACTION AND PROGRESSION TO OTHER AREAS OF MY BODY WITH PREVIOUS NICKEL SENSITIVITY FROM NICKEL JEWELRY MAKE ME THINK THIS MASK WAS CONTAMINATED WITH NICKEL, AND THE DERMATOLOGIST CONCURS THIS IS LIKELY. NEARLY A WEEK LATER MY SKIN CONTINUES TO BE ITCHY AND UNCOMFORTABLE AND IS NOW PEELING ON MY FACE. I CONTACTED THE MANUFACTURER IMMEDIATELY, AND THEY HAVE BEEN RESPONSIVE SO FAR - THEY ASKED FOR THE MASKS TO BE RETURNED SO THEY CAN EXAMINE THEM, AND I SHIPPED THEM BACK TO THEM BUT RETAINED TWO. ANOTHER AMAZON REVIEWER STATED JUST A COUPLE DAYS PRIOR THAT THE MASK MADE HER SKIN SO IRRITATED AND UNCOMFORTABLE SHE HAD TO REMOVE IT, WHICH I ALERTED THE MANUFACTURER TO AS WELL. I PROVIDED THE MANUFACTURER WITH THE DETAILS OF MY EXPERIENCE AND WITH THE PHOTOS I AM ATTACHING FOR YOU AS WELL. NOTE I DO NOT HAVE AN ALLERGY TO PP OR ANY OTHER MATERIALS. I WEAR OTHER N95 MASKS WITH NO PROBLEM.