inforMED
MalfunctionCAF

VIOS LC AEROSOL DELIV SYST

Received May 20, 2026

Report MW5188484 · MDR key 25233142

Device

Generic name

Nebulizer (direct Patient Interface)

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE PATIENT'S DAUGHTER REPORTED THAT WHEN USING OHTUVAYRE WITH THE NEW NEBULIZER IT'S NOT EMPTYING THE MEDICATION COMPLETELY AND THERE IS STILL A GOOD AMOUNT LEFT. THE PATIENT'S DAUGHTER WANTED TO KNOW IF THEY COULD USE A DIFFERENT TUBING AND MOUTH PIECE THAN PROVIDED AND SHE WILL CONTACT MDO TO FIND OUT IF A DIFFERENT TUBING AND MOUTH PIECE COULD BE USED. 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. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION.