MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,07 report with the FDA on 2001-08-21 for TOOTH CONDITIONER GEL 646125 manufactured by L.d. Caulk.
[244310]
A dentist was having trouble extruding tooth conditioner gel from the syringe after the first or second use. He pressed so hard on the syringe that the tip of the syringe came off and material went on the pt's shirt, face, and up the pt's nose. The pt was treated immediately with a nasal wash. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2001-00011 |
| MDR Report Key | 348560 |
| Report Source | 00,05,07 |
| Date Received | 2001-08-21 |
| Date of Report | 2001-08-21 |
| Date of Event | 2001-08-08 |
| Date Mfgr Received | 2001-08-08 |
| Date Added to Maude | 2001-08-27 |
| 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 | TOOTH CONDITIONER GEL |
| Generic Name | DENTAL RESTORATIVE MATERIAL |
| Product Code | EBC |
| Date Received | 2001-08-21 |
| Model Number | NA |
| Catalog Number | 646125 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 337876 |
| Manufacturer | L.D. CAULK |
| Manufacturer Address | 38 WEST CLARKE AVENUE 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. Other | 2001-08-21 |