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

Lot Number 678G8000

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Product/dose/frequency: altera handset: use as directed with cayston inhalation solution: reconstitute with provided diluent and inhale the contents of 1 vial via pari altera nebulizer 3 times a day for 28 days on and 28 days off.Patient reported that her altera handset nebulizer is not working and wanted to know how to replace it.Details not provided regarding how the device is not working and unknown if specialist aware.No adverse effects or missed doses reported as a result.Unknown if defective device is still on hand for return.No further information.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 15241996
• MDR Text Key: 298212525
• Report Number: MW5111506
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 678G8000
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: INHALATION SOLUTION
• Patient Sex: Female