inforMED
InjuryMSH

FLAT BREATHING MASK

Received May 4, 2020

Report MW5094379 · MDR key 10024940

Device

Generic name

Respirator, Surgical

Manufacturer

Unk

Product 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.