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