MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-10 for IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIAL 610200 manufactured by Dentsply Caulk.
[132596531]
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. Unable to test, incorrect lot# given.
Patient Sequence No: 1, Text Type: N, H10
[132596532]
It was reported that a patient experienced allergic reaction after undergoing a dental procedure with irm temporary restorative as one of the products. The patient was provided medication and reported that the reaction was non life threatening. The reaction subsided and no additional follow up is necessary at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2018-00014 |
| MDR Report Key | 8233429 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2019-01-10 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| 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 | IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIAL |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2019-01-10 |
| Model Number | NA |
| Catalog Number | 610200 |
| Lot Number | 1807000233 |
| 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 | 38 W. CLARK AVE. MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-10 |