MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-22 for LUCITONE 199 DENTURE BASE RESIN 688211 manufactured by Dentsply Prosthetics.
[48000735]
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. Retention product powder and liquid were tested and dhr's evaluated for abnormalities, no issues detected from either investigation.
Patient Sequence No: 1, Text Type: N, H10
[48000736]
A patient reported an allergic reaction to her full upper denture reline on (b)(6) 2016 to chemtrec. The patient reported experiencing numbness of the lips, palate swelling, headaches and reports a strong chemical taste. Removal of the device alleviates the patient's symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2585114-2016-00001 |
| MDR Report Key | 5743291 |
| Date Received | 2016-06-22 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2015-10-09 |
| Date Added to Maude | 2016-06-22 |
| 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 | 7178494229 |
| 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 | LUCITONE 199 DENTURE BASE RESIN |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2016-06-22 |
| Model Number | NA |
| Catalog Number | 688211 |
| Lot Number | 151009 |
| Device Expiration Date | 2019-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY PROSTHETICS |
| Manufacturer Address | 570 WEST COLLEGE AVENUE YORK PA 17404 US 17404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-22 |