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

Lot Number 031440

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Event Description

Spontaneous.Parent reported that they are having issues with the altera device (not further specified).Unknown if pt missed a dose; no adverse event reported; unknown if available for return; unknown if md aware.No further information provided.Device used to inhale cayston at above dose/frequency.Indication: moderate persistent asthma, uncomplicated, bronchopulmonary dysplasia originating in the perinatal period, tracheostomy status.Pneumonia due to pseudomonas, wheezing.Reported to (b)(6) by patient/caregiver.

• Brand Name: ALTERA HANDSET GILEAD
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 16411032
• MDR Text Key: 310045858
• Report Number: MW5115064
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 031440
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CAYSTON.
• Patient Sex: Female