MAUDE Adverse Event Report: ALBUTEROL INHALER; NEBULIZER

Lot Number DAC37A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

I am a proair hfa (albuterol) user.My doctor switched to this brand because the old brand was discontinued."the new prescription has acounter and i have had 2 stop at count 120 and empty.I took one of the canister back to the pharmacy and they could not understand why it was empty at 120 counts left showing and i got a replacement." my prescription is filled by military pharmacy, this is costing me money each prescription i get refill.I bring this matter to your attention in hope for a solution.Thank you, disabled veteran.

• Brand Name: ALBUTEROL INHALER
• Type of Device: NEBULIZER
• MDR Report Key: 6809688
• MDR Text Key: 83466989
• Report Number: MW5071734
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 5931057922
• UDI-Public: 59310-579-22
• 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: 08/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2018
• Device Lot Number: DAC37A
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 125