MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-05-14 for QHL75CURING LIGHT 506 644656 manufactured by L.d. Caulk.
[190492]
When the dentist removed the light from curing a composite on an upper arch tooth, the nose cone fell off and hit the patient's nose leaving a 12mm long cut about 2mm deep. The dentist was able to control the bleeding by applying direct pressure. According to the dentist no glass or debris entered the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2001-00004 |
| MDR Report Key | 333296 |
| Report Source | 00 |
| Date Received | 2001-05-14 |
| Date of Report | 2001-04-09 |
| Date of Event | 2001-03-10 |
| Date Mfgr Received | 2001-03-13 |
| Date Added to Maude | 2001-05-21 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM FREY, JR. |
| Manufacturer Street | 570 W. COLLEGE AVENUE P.O. BOX 872 |
| Manufacturer City | YORK PA 174050872 |
| Manufacturer Country | US |
| Manufacturer Postal | 174050872 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QHL75CURING LIGHT |
| Generic Name | DENTAL CURING LIGHT |
| Product Code | EAY |
| Date Received | 2001-05-14 |
| Model Number | 506 |
| Catalog Number | 644656 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 322670 |
| Manufacturer | L.D. CAULK |
| Manufacturer Address | 38 W. CLARKE AVENUE P.O. BOX 359 MILFORD DE 199630359 US |
| Baseline Brand Name | QHL75CURING LIGHT |
| Baseline Generic Name | DENTAL CURING LIGHT |
| Baseline Model No | 506 |
| Baseline Catalog No | 644656 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-14 |