MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-09-16 for CAULK TOOTH CONDITIONER GEL 34% 646125 manufactured by Dentsply Caulk.
[318757]
The doctor reported while extruding tooth conditioner gel the tip came off and the material went into their eye. The doctor immediately rinsed the eye with water and there was no report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2003-00124 |
| MDR Report Key | 484870 |
| Report Source | 05 |
| Date Received | 2003-09-16 |
| Date of Report | 2003-08-18 |
| Date of Event | 2003-08-11 |
| Date Mfgr Received | 2003-08-18 |
| Date Added to Maude | 2003-09-26 |
| 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 | DR. PATRICIA KIHN |
| Manufacturer Street | 570 WEST COLLEGE AVENUE |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARKE AVENUE |
| Manufacturer City | MILFORD DE 19963035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 0359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAULK TOOTH CONDITIONER GEL 34% |
| Generic Name | PIT & FISSURE SEALANT AND CONDITIONER |
| Product Code | EBC |
| Date Received | 2003-09-16 |
| Model Number | NA |
| Catalog Number | 646125 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 473763 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE. MILFORD DE 199630359 US |
| Baseline Brand Name | CAULK TOOTH CONDITION GEL 34% |
| Baseline Generic Name | PIT AND FISSURE SEALANT AND CONDITIONER |
| Baseline Model No | NA |
| Baseline Catalog No | 646125 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K942031 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-16 |