MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-21 for FYNAL PERMANENT ZOE CEMENT 609001 manufactured by Dentsply Caulk.
[78127832]
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 is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[78127833]
It was reported that a patient experienced allergic reaction after undergoing dental treatment with fynal zinc oxide eugenol cement. The swelling subsided on is own and no medical intervention was needed.
Patient Sequence No: 1, Text Type: D, B5
[113040834]
The device was evaluated and found to be within specification. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2017-00010 |
| MDR Report Key | 6658525 |
| Date Received | 2017-06-21 |
| Date of Report | 2017-08-24 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-06-21 |
| 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 | 7178457551 |
| 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 | 0 |
| Brand Name | FYNAL PERMANENT ZOE CEMENT |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2017-06-21 |
| Returned To Mfg | 2017-06-08 |
| Model Number | NA |
| Catalog Number | 609001 |
| Lot Number | 170113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2017-06-21 |