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 2019-03-06 for VIPI FLASH LIQUID V455 manufactured by Dentsply Brazil.
[138000510]
While it is unknown if the device used in this case caused or contributed to the health professional'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. Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[138000511]
A potential health professional allergic reaction to vipi flash liquid was reported by another health professional on (b)(6) 2019. The symptom experienced appears to be a form of contact dermatitis from handling of the pmma liquid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040288-2019-00002 |
| MDR Report Key | 8395867 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-06 |
| Date of Report | 2019-05-24 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-03-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 BRAZIL |
| Manufacturer Street | RUA ALICE HERVE 86, BINGEN |
| Manufacturer City | PETROPOLIS, 25665-010 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 25665-010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIPI FLASH LIQUID |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2019-03-06 |
| Model Number | NA |
| Catalog Number | V455 |
| Lot Number | 97414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY BRAZIL |
| Manufacturer Address | RUA ALICE HERVE 86, BINGEN PETROPOLIS, 25665-010 BR 25665-010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-06 |