MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-21 for PRIMARY CROWN CRIMPER 74-100 manufactured by Integra Lifesciences Corporation.
[111995301]
Patient Sequence No: 1, Text Type: N, H10
[111995302]
Tip of instrument broke off in patient's mouth during dental restoration procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7624538 |
| MDR Report Key | 7624538 |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-06-15 |
| Report Date | 2018-06-20 |
| Date Reported to FDA | 2018-06-20 |
| Date Reported to Mfgr | 2018-06-20 |
| Date Added to Maude | 2018-06-21 |
| 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 | 0 |
| Brand Name | PRIMARY CROWN CRIMPER |
| Generic Name | REMOVER, CROWN |
| Product Code | EIS |
| Date Received | 2018-06-21 |
| Catalog Number | 74-100 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-21 |