MAUDE Adverse Event Report: TEVA RESPIRATORY, LLC PROAIR HFA; INHALER, NEBULIZER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Asthma (1726)

Event Date 11/18/2016

Event Type  Injury  

Event Description

Reporter states that the inhaler prescribed for his asthma proair hfa does not relieve his asthma attacks (reporter is prescribed two puffs per attack).He says it instead makes his attacks worse.He says this seems to be the norm with this particular inhaler as so many others have given the same complaint via the internet.He is requesting that fda get this particular product off the market because according to him, there are many other inhalers that work very effectively and proair hfa is not one of them.He says allowing this product on the market will end up killing innocent people.

• Brand Name: PROAIR HFA
• Type of Device: INHALER, NEBULIZER
• Manufacturer (Section D): TEVA RESPIRATORY, LLC; 650 cathill road; sellersville PA 18960
• MDR Report Key: 6128630
• MDR Text Key: 61022022
• Report Number: MW5066332
• Device Sequence Number: 1
• Product Code: CAF
• 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: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 82