inforMED
MalfunctionCAF

VIOS LC AEROSOL DELIV SYST

Received Apr 6, 2026

Report MW5186402 · MDR key 24794221

Device

Generic name

Nebulizer (direct Patient Interface)

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE PATIENT REPORTED THE MEDICATION CUP TO AIR NOZZLE BLOWS OUT, BUT WHEN SHE PUTS TOP PART ON IT DOESN'T COME THROUGH AND THE OHTUVAYRE IS FOAMING UP IN THE CUP. DATE OF MALFUNCTION UNKNOWN. UNKNOWN IF PATIENT MISSED A DOSE. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF DEFECTIVE DEVICE IS ON HAND FOR RETURN. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED. DIAGNOSIS FOR USE: CHRONIC OBSTRUCTIVE PULMONARY DISEASE.