MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT INC ALTERA HANDSET; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Inbound call from patient states she does not have a working altera device.The altera device is using to administer her cayston medication.Start of cayston is unknown because the patient was on prior to using (b)(6) speciality.Ndc for cayston = 61958-0901-01 unknown if patient missed doses, experienced an adverse event or if the device is available for retrieval.Reported to (b)(6) by patient/caregiver.

• Brand Name: ALTERA HANDSET
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT INC
• MDR Report Key: 9859721
• MDR Text Key: 184516081
• Report Number: MW5093849
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1