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

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Indications: cystic fibrosis, unspecified and pulmonary mycobacterial infection; cayston ndc: 61958-0901- 01; solicited outbound call to patient.Patient reported she is in the hospital.Reason, date(s), and length of stay for the reported hospitalization are unknown.Unknown if specialist is aware.No further information.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: 11648059
• MDR Text Key: 245149263
• Report Number: MW5100684
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization