MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-17 for UNKNOWN EC3 / SG13/14 / 13/14 101-60540716-N manufactured by Henry Schein, Inc..
[89499250]
Patient Sequence No: 1, Text Type: N, H10
[89499271]
A metal piece from a root tip pick broke off inside of the patient's mouth during a dental procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6954286 |
| MDR Report Key | 6954286 |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-09-29 |
| Report Date | 2017-10-06 |
| Date Reported to FDA | 2017-10-06 |
| Date Reported to Mfgr | 2017-10-06 |
| Date Added to Maude | 2017-10-17 |
| 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 |
| 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 | UNKNOWN |
| Generic Name | INSTRUMENTS, DENTAL HAND |
| Product Code | DZN |
| Date Received | 2017-10-17 |
| Model Number | EC3 / SG13/14 / 13/14 101-60540716-N |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HENRY SCHEIN, INC. |
| Manufacturer Address | 85 MAPLE ST STONEHAM MA 02180 US 02180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |