MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-04-20 for DYCAL 61105501 manufactured by Dentsply Detrey.
[2747959]
In this event, it was reported that several days after placement of three provisional crowns during a procedure in which dycal was also placed, the pt returned to the office with discomfort, redness and pain in the associated area and slight swelling of the face. There is no indication that intervention was required to treat the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[9819763]
While it is unknown if the dycal used in this case caused or contributed to the pt's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2012-00007 |
| MDR Report Key | 2550648 |
| Report Source | 01,05 |
| Date Received | 2012-04-20 |
| Date of Report | 2012-03-23 |
| Date Mfgr Received | 2012-03-23 |
| Date Added to Maude | 2012-04-27 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE. 60 SUSQUENHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST 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 | DYCAL |
| Product Code | EJK |
| Date Received | 2012-04-20 |
| Catalog Number | 61105501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY |
| Manufacturer Address | KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-20 |