MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-02-28 for TOOTH CONDITIONER GEL 646125 manufactured by L.d. Caulk.
[15369828]
The doctor got the material in the pt's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2000-00001 |
| MDR Report Key | 266515 |
| Report Source | 05 |
| Date Received | 2000-02-28 |
| Date of Report | 2000-02-28 |
| Date of Event | 1999-11-04 |
| Date Mfgr Received | 1999-11-04 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 2000-03-06 |
| 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 AVE P.O. BOX 872 |
| Manufacturer City | YORK PA 174050872 |
| Manufacturer Country | US |
| Manufacturer Postal | 174050872 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOOTH CONDITIONER GEL |
| Generic Name | TOOTH CONDITIONER GEL |
| Product Code | EBC |
| Date Received | 2000-02-28 |
| Model Number | NA |
| Catalog Number | 646125 |
| Lot Number | 646125 |
| 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 | 258009 |
| Manufacturer | L.D. CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE. P.O. BOX 359 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. Required No Informationntervention | 2000-02-28 |