MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-03-12 for LUCITONE LIQUID 684309 manufactured by Dentsply Prosthetics.
[15811995]
In this event a customer reported that he had been using lucitone for years and recently began breaking out in sores when working with lucitone liquid, even when wearing gloves. The customer also reported that he has seen a dermatologist; however it is unknown if medical treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
[15884861]
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 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
| Report Number | 2515379-2014-00018 |
| MDR Report Key | 3690520 |
| Report Source | 00 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-02-14 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-02-14 |
| Device Manufacturer Date | 2013-05-31 |
| Date Added to Maude | 2014-03-21 |
| 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 |
| 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 | LUCITONE LIQUID |
| Generic Name | DENTURE RELINING RESIN |
| Product Code | EBI |
| Date Received | 2014-03-12 |
| Catalog Number | 684309 |
| Lot Number | 130531 |
| Device Expiration Date | 2014-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY PROSTHETICS |
| Manufacturer Address | YORK PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-12 |