MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-01 for STAR #61669 808-4911 manufactured by Star Dental.
[14958]
Registered hygenist was doing routine prophy on upper right quadrant when approximately 4mm of scaler tip broke off inpt's mouth and was evacuated by aspirator. Pt was not injured. Tip had been working normally up to the moment it broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411236-1993-00242 |
| MDR Report Key | 22854 |
| Date Received | 1994-09-01 |
| Date of Report | 1993-11-09 |
| Date of Event | 1993-11-05 |
| Date Facility Aware | 1993-11-09 |
| Report Date | 1993-11-09 |
| Date Reported to FDA | 1993-11-26 |
| Date Reported to Mfgr | 1993-11-26 |
| Date Added to Maude | 1995-06-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAR |
| Generic Name | TITANS PERIO TIP |
| Product Code | JEW |
| Date Received | 1994-09-01 |
| Model Number | #61669 |
| Catalog Number | 808-4911 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23076 |
| Manufacturer | STAR DENTAL |
| Manufacturer Address | 1816 COLONIAL VILLAGE LANE LANCASTER PA 17601 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-09-01 |