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

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Indication: carrier of other specified bacterial diseases.Frequency: 3 times a day for 28 days on and 28 days off; spontaneous call from (b)(6), nurse, who reported faulty equipment.Details and date of event not provided.Unknown if patient missed any doses.No adverse events reported as a result.Lot number and expiration date not provided.Unknown if patient has defective product on hand for return.No further information.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: 11529300
• MDR Text Key: 241473336
• Report Number: MW5100121
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• 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