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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(b)(6) at md office reported patient needs replacement altera kit (which includes the handset and grey cord that connects to the controller).Unknown reason for need fer replacement.Unknown if pt missed a dose; no adverse drug event reported; unk if device available for return; unknown lot/expiration.No further information known.Altera handset is used to deliver cayston inhalation solution at dose/frequency above.Reported to (b)(6) by health professional.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 12421607
• MDR Text Key: 270218545
• Report Number: MW5103718
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1