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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous: indication: cystic fibrosis with pulmonary manifestations.Spontaneous inbound call from patient.Patient reported that the altera device is not working.Unknown if pt missed a dose; no ade reported; unknown if device available for return; unknown if md aware; unknown lot/expiration.No further information provided.Directions: used with cayston 75 mg 3 times a day for 28 days on and 28 days off.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: 13059569
• MDR Text Key: 282776222
• Report Number: MW5106178
• 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: 12/06/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2021
• Patient Sequence Number: 1
• Patient Sex: Female