MAUDE Adverse Event Report: TEVA PHARMACEUTICAL INDUSTRIES LTD. QVAR; INHALER, NASAL

Lot Number 170270

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/14/2018

Event Type  malfunction  

Event Description

Reporter stated that the delivery system of qvar is malfunctioning.As instructed, patient shakes the cannister and tries to push the plastic dispenser however there is no compression as a result no medication comes out.With such failure, the customer is concerned that someone who is having an asthma attack will not be able to get the treatment needed.The customer went on saying that there is a safety concern of this failure.The customer is saying that this has been an ongoing issue with him.

• Brand Name: QVAR
• Type of Device: INHALER, NASAL
• Manufacturer (Section D): TEVA PHARMACEUTICAL INDUSTRIES LTD.
• MDR Report Key: 7348114
• MDR Text Key: 102881283
• Report Number: MW5075919
• 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
• Type of Report: Initial
• Report Date: 03/15/2018

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2019
• Device Lot Number: 170270
• Other Device ID Number: NDC #: 59310-204-12
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR