FDA Adverse Event
Malfunction
Summary report: N
INHALER
MDR report key: 20241094
·
Received September 16, 2024
Report
- Report Number
- MW5159644
- Event Type
- Malfunction
- Date Received
- September 16, 2024
- Report Date
- September 16, 2024
- Manufacturer
- LUPIN PHARMACEUTICALS INC. HARBORPLACE TOWER
- Product Code
- KCO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A REPORTER STATED THAT LUPIN INHALER IS MALFUNCTIONING AND ENDANGERING HIS PATIENTS¿ LIVES. HE STATED HE IS USING THE DEVICE AS WELL AND HE SAID, THE HOLE GETS PLUGGED WITH MEDICATION AND NOTING COMES OUT. HE SAID IT NEEDS TO BE CLEANED UP PERIODICALLY. HOWEVER, MOST OF HIS PATIENTS DO NOT KNOW THAT THE BLUE PLASTIC ACTUATOR SHOULD BE CLEANED UP SO MEDICATION DOES NOT BUILD UP. HE SAID HIS PATIENTS COME TO HIM FOR A DIFFERENT MEDICATION THINKING THE DEVICE DOES NOT WORK. HE EXPLAINS TO THEM THAT THE DEVICE WORKS BUT IT NEEDS TO BE CLEANED UP. HE SAID, HE LEFT A MESSAGE FOR THE MANUFACTURER, BUT HE DID NOT HEAR FROM THEM YET. HE SAID HE HAS BEEN USING IT FOR THE PAST 3 YEARS WITH THE SAME ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1318413 | INHALER | NASAL SPRAY, ENT DELIVERY | KCO | LUPIN PHARMACEUTICALS INC. HARBORPLACE TOWER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male |