MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA NEBULIZER SYSTEM FOR CAYSTON; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

Patient states that her cayston device is not working.It takes 10 minutes to start working.No further pertinent details provided.

• Brand Name: ALTERA NEBULIZER SYSTEM FOR CAYSTON
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 18464310
• MDR Text Key: 332436283
• Report Number: MW5149909
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN 125 MG/5ML ; PULMOZYME; SUSP RECON; TRIKAFTA
• Patient Age: 19 YR
• Patient Sex: Female