MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for SPOON EXCAVATOR D/E 14-19 manufactured by .
[44143448]
Pt was in the operating room for dental procedures. Tip off of the spoon excavator was noted to have broken off. Tip was retrieved and the piece and instrument were returned to csr. No post op images were required. Pt recovered and discharged as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061999 |
| MDR Report Key | 5620552 |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-04-15 |
| Date Added to Maude | 2016-04-29 |
| 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 |
| 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 | 0 |
| Brand Name | SPOON EXCAVATOR |
| Generic Name | SPOON EXCAVATOR |
| Product Code | EKC |
| Date Received | 2016-04-27 |
| Model Number | D/E 14-19 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-27 |