MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-06 for INTEGRITY MULTI-CURE 666600 manufactured by Dentsply Caulk.
[5479979]
In this event it was reported that a patient experienced an allergic reaction after undergoing a dental procedure that involved integrity. It began with a red ring around gingival of tooth #9. After several days it progressed to the gingival area of teeth 9-11 on the facial and lingual. The dentist then made the patient a new provisional and within minutes, the patients' upper lip became swollen, and the tip of her tongue became red. The patient took benadryl to combat the symptoms and was reportedly "doing better. "
Patient Sequence No: 1, Text Type: D, B5
[12988234]
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 and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2015-00009 |
| MDR Report Key | 4585171 |
| Report Source | 05 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Date Added to Maude | 2015-03-11 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRITY MULTI-CURE |
| Generic Name | CROWN AND BRIDGE, TEMPORARY, RESIN |
| Product Code | EBG |
| Date Received | 2015-03-06 |
| Catalog Number | 666600 |
| Lot Number | UNK |
| 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 | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-06 |