MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. ALTERA HANDSET (NO COST); NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Indication: pseudomonas aeruginosa (mallei) [pseudomallei) as the cause of diseases classified elsewhere.Patient spontaneously reported that the altera device was not working properly and keeps blinking red.Unknown if any adverse event or missed dose occurred.Unknown if patient still has defective device on hand.Unknown if specialist is aware.Dose and frequency: for use with cayston, reconstitute with provided diluent and inhale the contents of 1 vial (75 mg/vl) via pari altera nebulizer 3 times a day for 28 days on and 28 days off.Lot number, expiration date, or any other identifying numbers were not provided.No further information reported.Reported to (b)(6) by pt/caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 14488410
• MDR Text Key: 292794166
• Report Number: MW5109859
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female