MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-02 for EPIPEN 0.3 MG AUTOINJECTOR manufactured by Deypharma.
[2246679]
Epipen became stuck in pt after administration. When finally removed, needle was bent and appeared to have a burr at the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022147 |
| MDR Report Key | 2243950 |
| Date Received | 2011-09-02 |
| Date of Report | 2011-08-31 |
| Date of Event | 2011-08-31 |
| Date Added to Maude | 2011-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIPEN 0.3 MG AUTOINJECTOR |
| Generic Name | AUTOINJECTOR |
| Product Code | KZE |
| Date Received | 2011-09-02 |
| Lot Number | 06H797 |
| ID Number | 49502 50001 |
| Device Expiration Date | 2012-06-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEYPHARMA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-02 |