MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for DENTAL BUR DIAMOND manufactured by Unk.
[179299142]
Same day surgery had 2 of the fg878 dental burs break during two separate cases. Both pieces on both cases were recovered. No harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092951 |
| MDR Report Key | 9699783 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-02-12 |
| 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 | RISK MANAGER |
| 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 | DENTAL BUR DIAMOND |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2020-02-11 |
| Lot Number | 1603914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | DENTAL BUR DIAMOND |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2020-02-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |