MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-13 for INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM 666220 manufactured by Dentsply Caulk.
[31076845]
While it is unknown if the device used in this case caused or contributed to the patient'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. The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[31076846]
In this event it was reported that a patient experienced allergic reaction after undergoing a dental procedure with integrity temporary c&b material as one of the materials. The dentist stated that he believes that the patient is allergic to methacrylates as they are both present in the temporary material and in the permanent cement that he used. It was reported that around tooth #19, there was sloughing on the cheek and tongue about 1/2cm x 3cm with a white coating. The dentist prescribed percocet for pain management and benedryl to combat the reaction. The patient recovered three days after treatment.
Patient Sequence No: 1, Text Type: D, B5
[39594602]
Retain product was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2015-00071 |
| MDR Report Key | 5221293 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-13 |
| Date of Report | 2015-10-13 |
| Date Mfgr Received | 2016-02-04 |
| Date Added to Maude | 2015-11-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARK 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 | INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM |
| Generic Name | CROWN AND BRIDGE, TEMPORARY, RESIN |
| Product Code | EBG |
| Date Received | 2015-11-13 |
| Model Number | NA |
| Catalog Number | 666220 |
| Lot Number | 140923 |
| 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 CAULK |
| Manufacturer Address | 38 W. CLARK AVE. MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-13 |