MAUDE Adverse Event Report: TEVA PHARMACEUTICAL PROAIR HFA; PUMP

Device Problems Product Quality Problem (1506); Failure to Deliver (2338)

Patient Problem Respiratory Distress (2045)

Event Date 01/04/2018

Event Type  Injury  

Event Description

Reporter states that the proair pump was unable to deliver treatment as expected when a (her) child went into respiratory distress yesterday.According to reporter, she has used hundreds of this pump with almost similar malfunction which makes her think the product (pump) is of poor quality and of no good and as such should be taken off the market.Per reporter, fda needs to take immediate action against this manufacturer to prevent what her child experienced from happening to any other child.

• Brand Name: PROAIR HFA
• Type of Device: PUMP
• Manufacturer (Section D): TEVA PHARMACEUTICAL
• MDR Report Key: 7171436
• MDR Text Key: 96810774
• Report Number: MW5074435
• Device Sequence Number: 1
• Product Code: KCO
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening