FDA Adverse Event
Malfunction
Summary report: N
PROAIR HFA
MDR report key: 2740462
·
Received September 5, 2012
Report
- Report Number
- MW5026826
- Event Type
- Malfunction
- Date Received
- September 5, 2012
- Date of Event
- September 3, 2012
- Report Date
- September 3, 2012
- Manufacturer
- IVA/TEVA
- Product Code
- CCQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT STATES CANNISTER NOT WORKING WITH THE SLEEVE. PUFF GOES UP IN THE AIR AND NOT OUT. WILL WORK WHEN CANNISTER IS PUT IN ANOTHER SLEEVE. THINKS MULTIPLE SLEEVES ARE DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROAIR HFA | CANNISTER | CCQ | IVA/TEVA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |