MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-02-13 for DELTON PIT & FISSURE SEALANT 279415 manufactured by Dentsply Professional Division.
[225992]
When applying the etchant to the pt's tooth, the end of the cartrigde detached resulting in the contents of the cartridge being extruded into the pt's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2001-00001 |
| MDR Report Key | 316236 |
| Report Source | 05 |
| Date Received | 2001-02-13 |
| Date of Report | 2001-02-09 |
| Date Mfgr Received | 2001-01-18 |
| Date Added to Maude | 2001-02-20 |
| 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 | 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 | 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 | DELTON PIT & FISSURE SEALANT |
| Generic Name | DENTAL SEALANT |
| Product Code | EMN |
| Date Received | 2001-02-13 |
| Model Number | NA |
| Catalog Number | 279415 |
| Lot Number | 000204 |
| ID Number | * |
| Device Expiration Date | 2002-02-01 |
| 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 | 305798 |
| Manufacturer | DENTSPLY PROFESSIONAL DIVISION |
| Manufacturer Address | P.O. BOX 7807 1301 SMILE WAY YORK PA 174050807 US |
| Baseline Brand Name | DELTON PIT & FISSURE SEALANT |
| Baseline Generic Name | DENTAL SEALANT |
| Baseline Model No | NA |
| Baseline Catalog No | 279415 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-02-13 |