MAUDE Adverse Event Report: TEVA QVAR INHALER

Device Problem No Flow (2991)

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

Event Date 03/25/2016

Event Type  Injury  

Event Description

Reporter stated that she started using the device on (b)(6) 2016.On (b)(6) 2016, the medication would not flow out of the device.Manufacturer refuses to replace the faulty inhaler.

• Brand Name: QVAR INHALER
• Type of Device: QVAR INHALER
• Manufacturer (Section D): TEVA; PA 19454
• MDR Report Key: 5537474
• MDR Text Key: 41619975
• Report Number: MW5061348
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/28/2016

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
• Other Device ID Number: 140343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 72