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