MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-04-03 for DELTON LC UNK manufactured by Preventive Care Division.
[180629]
The pt had a fissure sealing on the four first molars at 9 am. Two hrs later the pt's cheeks were swollen and full of big light blisters. In addition, pt's hands showed swelling and a reddish rash. Pt's body itched, and pt was pale and felt sick. Two dentists diagnosed an anaphylactic shock. The pt was given an injection of 0. 3 ml adrenaline 1mg/ml subgigivally and 0. 5 ml decadrone 4 mg/dl in the thigh. At the same time, an anbulance was called. After two minutes pt's condition was clearly better. The swelling and the rash were quickly decreasing. The ambulance arrived and the rescue team confirmed the above diagnosis. The pt was taken to the emergency room and at 1 pm was much better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2000-00004 |
| MDR Report Key | 272157 |
| Report Source | 05 |
| Date Received | 2000-04-03 |
| Date of Report | 2000-03-31 |
| Date of Event | 1999-12-06 |
| Date Mfgr Received | 2000-03-21 |
| Date Added to Maude | 2000-04-06 |
| 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 | 7178494219 |
| 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 LC |
| Generic Name | PIT & FISSURE SEALANT |
| Product Code | EBC |
| Date Received | 2000-04-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | 990317 |
| 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 | 263470 |
| Manufacturer | PREVENTIVE CARE DIVISION |
| Manufacturer Address | 1301 SMILE WAY P.O. BOX 7807 YORK PA 174050807 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-03 |