MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-01-22 for 430 K SW HANDPIECE 362057 62057 manufactured by Dentalez Group.
[144422]
Dr was performing a crown prep on #29 tooth. Pt was burned on lower lip. Dr applied salve to burn mark.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520265-1998-00005 |
| MDR Report Key | 207277 |
| Report Source | 05 |
| Date Received | 1999-01-22 |
| Date of Event | 1998-12-22 |
| Date Mfgr Received | 1998-12-22 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1999-01-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 430 K SW HANDPIECE |
| Generic Name | 430 K SW HANDPIECE |
| Product Code | EJB |
| Date Received | 1999-01-22 |
| Returned To Mfg | 1999-01-21 |
| Model Number | 362057 |
| Catalog Number | 62057 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201195 |
| Manufacturer | DENTALEZ GROUP |
| Manufacturer Address | 1816 COLONIAL VILLAGE LN. LANCASTER PA 17601 US |
| Baseline Brand Name | 430 K SW HANDPIECE |
| Baseline Generic Name | 430 K SW HANDPIECE |
| Baseline Model No | 362057 |
| Baseline Catalog No | 62057 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-01-22 |