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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient's mom reports patient had recent hospitalization.Reason, dates, and length of stay for the reported hospitalization are unknown.No other information provided.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: 11229105
• MDR Text Key: 228913846
• Report Number: MW5098994
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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