FDA Adverse Event
Summary report: N
GREENSTONE
MDR report key: 2161650
·
Received July 8, 2011
Report
- Report Number
- 2161650
- Date Received
- July 8, 2011
- Date of Event
- June 23, 2011
- Report Date
- July 8, 2011
- Manufacturer
- GREENSTONE LLC
- Product Code
- KZE
- Report Source
- User Facility report
- Reporter Location
- WI, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS HAVING AN ALLERGIC REACTION DURING A FOOD CHALLENGE IN THE ALLERGY CLINIC. THE NURSE MADE TWO INJECTION ATTEMPTS WITH A GREENSTONE 0.15MG AUTO-INJECTOR. THE INJECTOR FAILED TO DEPLOY. A SECOND INJECTOR FROM A DIFFERENT BRAND WAS OBTAINED AND DEPLOYED. TREATMENT WAS DELAYED, BUT THE PATIENT WAS NOT HARMED. THERE HAS BEEN ONE PRIOR EVENT IN (B)(6) OF THIS YEAR WHERE THE GREENSTONE BRAND AUTO-INJECTOR COULD NOT BE DEPLOYED.======================MANUFACTURER RESPONSE FOR EPINEPHRINE AUTO-INJECTOR PEN, GREENSTONE (PER SITE REPORTER)======================THE HOSPITAL HAS INVITED GREENSTONE TO SEND A REPRESENTATIVE TO INSPECT THE INJECTOR. THE INJECTOR WILL REMAIN AT THE HOSPITAL FOR NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENSTONE | EPINEPHRINE AUTO-INJECTOR PEN | KZE | GREENSTONE LLC | * | G1003032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 MO | NO OTHER THERAPIES |