MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-02-14 for COLTOLUX CURING LIGHT C-7921 manufactured by Coltene/whaldent Inc..
[48269]
Received a telephone call that reported that the light guide of a curing light had "exploded" in the pt's mouth while light curing a restoration. Due to the fact that the dentist had placed rubber dam, there were no adverse effects to the pt. The light guide is all an accessory device to the curing light.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-1997-00001 |
| MDR Report Key | 70416 |
| Report Source | 00 |
| Date Received | 1997-02-14 |
| Date of Report | 1997-02-13 |
| Date of Event | 1997-02-04 |
| Date Mfgr Received | 1997-02-04 |
| Date Added to Maude | 1997-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLTOLUX CURING LIGHT |
| Generic Name | VISIBLE LIGHT CURING DENTAL MATERIAL |
| Product Code | EAY |
| Date Received | 1997-02-14 |
| Model Number | C-7921 |
| Catalog Number | C-7921 |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 70331 |
| Manufacturer | COLTENE/WHALDENT INC. |
| Manufacturer Address | 750 CORPORATE DRIVE MAHWAH NJ 074302009 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-14 |