Manufacturer Contact Information for Qvar (Beclomethasone) Device Issues
For defective Qvar inhaler devices, patients should contact the manufacturer directly, though the specific phone number is not provided in the available evidence; however, defective medical devices should be reported to the FDA's MedWatch program at 800-332-1088.
Reporting Defective Medical Devices
- The FDA MedWatch program is the primary system for reporting medical device faults and malfunctions at 800-332-1088 1
- Device faults include unintended failures in design, manufacture, or use that lead to or have potential to cause patient harm 2
- Over 70% of medical device faults arise at the design stage, approximately 25% during manufacture, and less than 5% from faulty use 2
Alternative Reporting Pathways
- Healthcare providers can report device problems through the Vaccine Adverse Events Reporting System (VAERS) at 800-822-7967 for vaccine-related devices, though this is primarily for vaccines rather than inhaler devices 1
- Web-based reporting is available through the FDA MedWatch website at http://www.fda.gov/medwatch 1
Practical Steps for Device Replacement
- Contact the pharmacy where the device was dispensed first, as they may facilitate direct manufacturer contact or replacement
- Keep the defective device and packaging with lot numbers for reporting purposes, as manufacturers require this information for investigation 1
- Document the specific malfunction (e.g., dose counter failure, actuator problems, leaking canister) as nearly 70% of reported device faults involve devices that enter the body 2
Important Caveats
- The manufacturer's package insert should contain specific contact information for device complaints, which pharmacists can access 1
- Reporting to FDA does not guarantee immediate device replacement but creates a safety record that may prevent future incidents 2
- Patients should not continue using a malfunctioning inhaler, as proper drug delivery is essential for asthma control 3, 4, 5