MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-19 for ORTHODONTIC RESIN 651003 manufactured by Dentsply Caulk.
[2897122]
In this event it was reported that a patient experienced swelling of the lips after having an appliance made that incorporated the use of clear orthodontic liquid. The pt was given benadryl to combat the reaction, and stop using the appliance. Follow up determined that the pt was doing fine and that all symptoms related to the materials use had subsided.
Patient Sequence No: 1, Text Type: D, B5
[10153853]
While it is unk if the device 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. The device will not be returned for evaluation. A dhr review is planned and results will be submitted once they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2012-00012 |
| MDR Report Key | 2757094 |
| Report Source | 05 |
| Date Received | 2012-09-19 |
| Date of Report | 2012-08-21 |
| Date Mfgr Received | 2012-08-21 |
| Date Added to Maude | 2012-09-26 |
| 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 SUSQUEHANNA 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 | ORTHODONTIC RESIN |
| Product Code | EBI |
| Date Received | 2012-09-19 |
| Catalog Number | 651003 |
| Lot Number | 100527 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-19 |