MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-11 for SUMAVEL DOSEPRO 6 MG manufactured by Zogenix.
[2025287]
(b)(6) - pt came in with a migraine. Asked to be given above product. It was primed and placed against the skin. It did not activate, so it was tried two more times. At this point, i pulled it away from the pt and within 3 seconds, it self-actuated, forcefully discharging contents into the air. It did not strike the pt or myself but was between both of us as it was being moved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020575 |
| MDR Report Key | 2089925 |
| Date Received | 2011-05-11 |
| Date of Report | 2011-05-05 |
| Date of Event | 2011-05-05 |
| Date Added to Maude | 2011-05-19 |
| 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 |
| 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 | SUMAVEL DOSEPRO 6 MG |
| Generic Name | TRANSDERMAL |
| Product Code | KZE |
| Date Received | 2011-05-11 |
| Lot Number | 020688 |
| Device Expiration Date | 2012-02-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOGENIX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-11 |