MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-01 for STAR DENTAL HANDPIECE 430 SW manufactured by Star Dental.
[74429640]
Dentist was using handpiece when she noticed that burr was wobbling and ultimately came out of the handpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069530 |
| MDR Report Key | 6541143 |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-04-19 |
| Date Added to Maude | 2017-05-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STAR DENTAL HANDPIECE |
| Generic Name | ALLOY, METAL, BASE |
| Product Code | EJH |
| Date Received | 2017-05-01 |
| Model Number | 430 SW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STAR DENTAL |
| Manufacturer Address | LANCASTER PA 17601 US 17601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-01 |