MAUDE Adverse Event Report: TEVA PHARMACEUTICALS USA PROAIR HFA; INHALER

Model Number DAD03A

Device Problem Obstruction of Flow (2423)

Patient Problem Respiratory Distress (2045)

Event Date 02/10/2018

Event Type  Injury  

Event Description

Caller stated while attempting to use inhaler, she found the device was delivering a white substance which was found clogged within the device.Caller was unable to receive her inhalant and experienced respiratory issues.Caller was admitted to the hospital where she stayed overnight to treat her lungs.

• Brand Name: PROAIR HFA
• Type of Device: INHALER
• Manufacturer (Section D): TEVA PHARMACEUTICALS USA
• MDR Report Key: 7285534
• MDR Text Key: 100692098
• Report Number: MW5075366
• Device Sequence Number: 1
• Product Code: CAF
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2019
• Device Model Number: DAD03A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR