MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for VISCO-GEL TISSUE TREATMENT MATERIAL 61605002 manufactured by Dentsply Detrey Gmbh.
[31182164]
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
[31182185]
In this event it was reported that a patient experienced an allergic reaction to visco-gel approximately 3 to 4 hours after coming in contact with the product. The patient suffered from severe inflammation on their gums and tongue, causing her to remove the device. To date, although she did not put the device in place, inflammation persists, with the presence of canker sores on the edge of the tongue.
Patient Sequence No: 1, Text Type: D, B5
[39107452]
Multiple unsuccessful attempts were made to obtain the device for evaluation. The device was not returned for evaluation and the lot number that was provided is not valid. Therefore, retained-product testing and/or dhr review is not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2015-00072 |
| MDR Report Key | 5223165 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-10-16 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2015-11-13 |
| 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 | 3 |
| Brand Name | VISCO-GEL TISSUE TREATMENT MATERIAL |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2015-11-13 |
| Model Number | NA |
| Catalog Number | 61605002 |
| Lot Number | UNK |
| Device Expiration Date | 2017-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ, 78467 GM 78467 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-13 |