MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for EPIPEN manufactured by Mylan Pharmaceuticals Inc..
[185926952]
I noticed that the blue part of my epipen was already raised even though it has never been removed from its case until today to check if it fell into the group in the epipen failure group. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093970 |
| MDR Report Key | 9902658 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-26 |
| Date Added to Maude | 2020-03-31 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPIPEN |
| Generic Name | INJECTOR, PEN |
| Product Code | NSC |
| Date Received | 2020-03-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |