MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-10 for DELTON PIT & FISSURE SEALANT 27961 manufactured by Dentsply Caulk.
[384053]
A pt experienced swelling and itching of the tongue and cheek after use of delton, indicating a possible allergic reaction to the material of a constituent part. The symptoms resolved without the medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2005-00017 |
| MDR Report Key | 572127 |
| Report Source | 05 |
| Date Received | 2005-02-10 |
| Date of Report | 2005-01-14 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2005-02-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST., STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARKE AVE. |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTON PIT & FISSURE SEALANT |
| Generic Name | PIT AND FISSURE SEALANT AND CONDITIONER |
| Product Code | EBC |
| Date Received | 2005-02-10 |
| Model Number | NA |
| Catalog Number | 27961 |
| Lot Number | 0405041 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 561996 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | * MILFORD DE * US |
| Baseline Brand Name | DELTON PIT & FISSURE SEALANT LIGHT CURE |
| Baseline Generic Name | PIT & FISSURE SEALANT AND CONDITIONER |
| Baseline Model No | NA |
| Baseline Catalog No | 27961 |
| Baseline ID | NA |
| Baseline Device Family | CALIBRA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K831380 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-10 |