MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-26 for DLASE 300 PLUS manufactured by Sunrise Technologies.
[17804755]
On 9/21/94,dr. St a dr. Orally reported a female pt of his suffered a loss of two teeth. The dr. Stated that a dental laser had been used for tissue retraction and for treatment of a cyst. There is insufficient information directly relating the loss of the two teeth to use of the laser. However, this report is being made because a laser was used as a part of the pt's treatment. The dr. Did not relate the tooth loss to his use of the laser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833683-1994-00001 |
| MDR Report Key | 19097 |
| Date Received | 1994-10-26 |
| Date of Report | 1994-09-30 |
| Date Facility Aware | 1994-09-21 |
| Report Date | 1994-09-30 |
| Date Reported to FDA | 1994-09-30 |
| Date Reported to Mfgr | 1994-09-30 |
| Date Added to Maude | 1995-01-24 |
| 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 |
| 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 | DLASE 300 PLUS |
| Generic Name | DENTAL LASER |
| Product Code | LYB |
| Date Received | 1994-10-26 |
| Model Number | DLASE 300 PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 36 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19022 |
| Manufacturer | SUNRISE TECHNOLOGIES |
| Manufacturer Address | 257 FREMONT BLVD. FREMONT CA 94538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-10-26 |