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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fibrosis (3167)

Event Type  Injury  

Event Description

Indication: cystic fibrosis with pulmonary manifestation.Solicited patient reported hospitalization since last refill.No additional information provided.Dates, length of stay, and reason not reported.Route of administration for altera handset use with cayston.Reported to (b)(6) by patient/caregiver.

• Brand Name: ALTERAHANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 10801092
• MDR Text Key: 215319213
• Report Number: MW5097689
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization