FDA Adverse Event
Malfunction
Summary report: N
VENTOLIN HFA METERED DOSE INHALER
MDR report key: 9225875
·
Received October 22, 2019
Report
- Report Number
- MW5090589
- Event Type
- Malfunction
- Date Received
- October 22, 2019
- Report Date
- October 22, 2019
- Manufacturer
- GLAXOSMITHKLINE (GSK)
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER STATED THAT HE HAS COPD TAKES A VENTOLIN HFA INHALER. HE SAID THAT IT CONTAINS 144 METERED INHALATIONS BUT AFTER "60 TO 80 PUFFS" IT NO LONGER DISPENSES. HE IS CONCERNED BECAUSE HIS MEDICATION PROGRAM ONLY PROVIDES A 3 MONTH SUPPLY AND HE IS RUNNING OUT IN HALF THE TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1011853 | VENTOLIN HFA METERED DOSE INHALER | NEBULIZER (DIRECT PATIENT INTERFACE) | CAF | GLAXOSMITHKLINE (GSK) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |