MAUDE Adverse Event Report: PRASCO ADVAIR DISKUS; INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED

Device Problem Complete Blockage (1094)

Patient Problem Respiratory Insufficiency (4462)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

Reporter calling, stating that her inhaler mouthpiece is "stuck, it won't open" and "i can't get my advair." she states she recently had bronchitis and she very much needs her advair to breathe normally.The inhaler worked "the first few times" she used it but the cap is now stuck and she is unable to remove it to inhale her medication as prescribed.She states that her pharmacy is refusing to replace it and "i don't have the 400 dollars" to replace it.Reporter is frustrated this is happening and has been without her advair since (b)(6) 2023, and is finding it increasingly difficult to breathe.

• Brand Name: PRASCO ADVAIR DISKUS
• Type of Device: INHALER, METERED DOSE OR DRY POWDER, CDER OR CBER LED
• MDR Report Key: 16381001
• MDR Text Key: 309779306
• Report Number: MW5114971
• Device Sequence Number: 1
• Product Code: QKS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: PRASCO ADVAIR 250/50
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female