MAUDE Adverse Event Report: VENTOLIN HFA AEROSOL; INHALER

Device Problem Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 01/30/2016

Event Type  Injury  

Event Description

Reporter stated that six months ago, her doctor changed the pro air device she was using to the ventolin hfa aerosol.She later discovered the device was running her blood pressure high.She still uses the device and has an appointment with the md later today to discuss the issue.

• Brand Name: VENTOLIN HFA AEROSOL
• Type of Device: INHALER
• MDR Report Key: 5980012
• MDR Text Key: 55795226
• Report Number: MW5065044
• 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: Other
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Other Device ID Number: NDC#00173-60682-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 63