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

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous inbound call from patient's mom (b)(6), stated they need a replacement altera nebulize due to device not working properly.Lot number and expiration date unknown.Unknown if patient experienced an adverse event due to the defective product.Unknown if patient had any missed doses.Unknown if patient has the product on hand.No other information.Indication: cystic fibrosis with pulmonary manifestations.Reported to (b)(6) by: patient/caregiver.

• Brand Name: ALTERA HANDSET (NO COST)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 11435251
• MDR Text Key: 238869039
• Report Number: MW5099829
• 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: 01/12/2021

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Patient Sequence Number: 1