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

Device Problems Loose or Intermittent Connection (1371); Gas/Air Leak (2946)

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

Event Type  Injury  

Event Description

Pt reports: "pari altera nebulizer handset is defective.It leaks and pt reported "i am sure i have put it together correctly".The problem is the piece with the metal disk.It snaps into place but one side is still loose and the medication escapes from this area so i am not getting a full dose each time i use the nebulizer".Unknown if pt had any adverse events or side effects from med leaking.New device being sent to pt for 10/25/2022.Serial number not reported for handset.No additional information available.Unknown if pt has device on hand for return to manufacturer.Consent question was not asked and the "no" is selected by default.Indication: other bacterial infections of unspecified site, unspecified chronic bronchitis cayston dose/frequency: reconstitute with provided diluent and inhale the contents of 1 vial via pari altera nebulizer 3 times a day for 28 days on and 28 days off.Reported to cvs/caremark 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: 15679909
• MDR Text Key: 302604123
• Report Number: MW5112888
• 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: 10/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male