MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for DENTAL DRILL manufactured by Unk.
[90861286]
During a wisdom tooth extraction, at (b)(6) oral surgery in (b)(6), i was burned repeatedly on the face and lip by an overheating dental drill. I informed my dentist several times that what he was doing hurt me. He did not stop until after the third warning. I received second degree burns on my face and lip and went to the emergency room. The office has not compensated me or mitigated the damages in any way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073072 |
| MDR Report Key | 6993550 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-10-28 |
| Date of Event | 2017-10-25 |
| Date Added to Maude | 2017-11-01 |
| 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 |
| 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 | 0 |
| Brand Name | DENTAL DRILL |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-11-01 |