FDA Adverse Event
Summary report: N
PROAIR HFA
MDR report key: 811757
·
Received January 23, 2007
Report
- Report Number
- MW1041742
- Date Received
- January 23, 2007
- Date of Event
- November 1, 2006
- Report Date
- January 23, 2007
- Manufacturer
- IVAX PHARMACY, IRELAND, IVAX LAB
- Product Code
- CAF
- Report Source
- Voluntary report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER IS PATIENT WHO STATES DOCTOR CHANGED HER ALBUTEROL INHALER TO A MORE GENERIC BRAND CALLED "PROAIR." SHE STATES THAT THE DEVICE, WHEN TRIGGERED, SUCKS MEDICATION BACK OUT, RATHER THAN INTO HER BODY AS DID HER ORIGINAL ALBUTEROL INHALER. THE "PROAIR" IS NOT WORKING FOR HER. THE PHARMACIST HAS REPLACED THE DEVICE TWICE IN THE PAST 2 MONTHS. THE DEVICE WORKS IN REVERSE. SHE'S NEVER HAD THIS PROBLEM BEFORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROAIR HFA | INHALER | CAF | IVAX PHARMACY, IRELAND, IVAX LAB | * | ADH22A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |