FLAT BREATHING MASK
Received May 4, 2020
Report MW5094379 · MDR key 10024940
Device
Generic name
Respirator, Surgical
Manufacturer
UnkProduct problems
- Patient-Device Incompatibility
Patient
Not reported
- Dyspnea
- Reaction
- Dyspnea
- Reaction
Narrative
Description of Event or Problem
PATIENT CALLED TO REPORT ADVERSE REACTION TO TWO KINDS OF FACE MASKS. PATIENT STATED THESE TWO TYPES OF MASKS ARE NOT SAFE FOR PEOPLE WITH RESPIRATORY CONDITIONS. PATIENT SAID THESE MASKS CAN CAUSE REVERSE RESPIRATION. PATIENT SAID THE MASKS MAKE IT HARD TO BREATHE A FULL BREATH CYCLE AND DOESN'T ALLOW THE PERSON TO GET ENOUGH OXYGEN, WHICH IS BAD FOR THE HEART AND CAN WEAKEN THE RESPIRATORY SYSTEM. PATIENT SAID SHE CAN'T FULLY BREATH IF SHE'S WEARING THESE MASKS. PATIENT SAID SHE BELIEVES SPECIAL ACCOMMODATIONS NEED TO BE IN PLACE FOR PEOPLE WITH RESPIRATORY CONDITIONS. PATIENT FEELS A RESPIRATOR MASK WOULD BE MORE HELPFUL FOR HER. PATIENT WOULD LIKE ASSISTANCE FROM FDA IN GETTING RESPIRATOR MASKS FOR HER SO SHE CAN BREATHE BETTER.