FDA Adverse Event
Injury
Summary report: N
PROAIR HFA
MDR report key: 7837150
·
Received August 30, 2018
Report
- Report Number
- MW5079516
- Event Type
- Injury
- Date Received
- August 30, 2018
- Report Date
- August 30, 2018
- Manufacturer
- IVAX PHARMACEUTICAL / TEVA PHARMACEUTICAL
- Product Code
- KCO
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
REPORTER STATED THAT NINE MONTHS AGO, HIS DR PRESCRIBED INHALER FOR HIS ASTHMA ATTACK. HOWEVER, THE MEDICATION HE RECEIVED WAS DIFFERENT FROM WHAT HIS DR PRESCRIBED. HE WAS HAVING PAIN, FEVER, BECAME LETHARGIC, GETTING SLOWER AND SLOWER. HE SAID HE COULD NOT FIGURE OUT WHY HE WAS FEELING THIS WAY. HE STOPPED THE MEDICATION 2 DAYS AGO, AND HIS PAIN SUBSIDING. HE BELIEVED THAT THE MEDICATION IS CONTAMINATED FOR HIM TO HAVE THESE KIND OF ALLERGIC REACTION. HE ALSO THINKS THEY ARE SELLING THE MEDICATION AT A DISCOUNT RATE BECAUSE IT IS CONTAMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 676859 | PROAIR HFA | INHALER, NASAL | KCO | IVAX PHARMACEUTICAL / TEVA PHARMACEUTICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |