MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-08 for GREENSTONE * manufactured by Greenstone Llc.
[2137932]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2161650 |
| MDR Report Key | 2161650 |
| Date Received | 2011-07-08 |
| Date of Report | 2011-07-08 |
| Date of Event | 2011-06-23 |
| Report Date | 2011-07-08 |
| Date Reported to FDA | 2011-07-08 |
| Date Added to Maude | 2011-07-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENSTONE |
| Generic Name | EPINEPHRINE AUTO-INJECTOR PEN |
| Product Code | KZE |
| Date Received | 2011-07-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | G1003032 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREENSTONE LLC |
| Manufacturer Address | 100 ROUTE 206 NORTH PEAPACK NJ 07977 US 07977 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-08 |