MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for BRASSELER DENTAL HANDPIECE manufactured by Brasseler Usa Dental, Llc..
[135744027]
Suffered a severe burn on my tongue from a brasseler dental handpiece. This was 2 weeks ago, and the burn was so deep that it is still not healed. For at least 7 days, i suffered extreme pain from this burn making it difficult to eat, sleep or talk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083723 |
| MDR Report Key | 8310605 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-18 |
| Date Added to Maude | 2019-02-06 |
| 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 | BRASSELER DENTAL HANDPIECE |
| Generic Name | HANDLE, INSTRUMENT, DENTAL |
| Product Code | EJB |
| Date Received | 2019-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRASSELER USA DENTAL, LLC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-05 |