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

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The patient reported that she won't be scheduling the medication until she gets the replacement for her altera device because she wants that settled first.It is unknown how the device broke or what the malfunction was.It is unknown if an adverse event or missed dose occurred.It is unsure if the patient still has the defective device for return to the manufacturer.No further information was provided.Used for cayston dose or amount and frequency: reconstitute with provided diluent and inhale the contents of 1 vial (75mg) via pari altera nebulizer 3 times a day for 28 days on and 28 days off.No lot tracked in system for device.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: 15659465
• MDR Text Key: 302493624
• Report Number: MW5112813
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: NO LOT
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAYSTON
• Patient Sex: Female