MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for EP IMPLANT TRAY manufactured by .
[23533077]
Patient Sequence No: 1, Text Type: N, H10
[23533078]
The outside packaging of ep implant tray was inspected for damage. The package was opened. A small piece of the blue wrap was found on table after the outer clear package was removed. This prompted further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5017555 |
| MDR Report Key | 5017555 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-08 |
| Date of Event | 2015-06-08 |
| Report Date | 2015-07-08 |
| Date Reported to FDA | 2015-07-08 |
| Date Reported to Mfgr | 2015-07-08 |
| Date Added to Maude | 2015-08-20 |
| 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 | 3 |
| 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 | EP IMPLANT TRAY |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2015-08-20 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |