MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-08-28 for VISCO-GEL 61605002 manufactured by Dentsply Caulk.
[20661156]
In this event it was reported that a doctor ordered visco-gel tissue treatment kit and received a package of visco-gel temporary soft denture liner with a broken seal. After mixing the liquid with powder, the doctor noted a milky mass with bitter taste and a burning sensation to the mucous membranes of the mouth. The doctor returned the visco-gel temporary soft denture liner with the broken seal and thought he would receive visco-gel tissue treatment kit with unbroken seals. After a short time the doctor received the same product. The doctor had a small amount of liquid from a previous visco-gel tissue treatment kit and decided to mix it with the powder from visco-gel temporary soft denture liner and noted a transparent mixture as it would look if the powder from visco-gel tissue treatment kit was used. The doctor used this mixture on several patients. The patients reported experiencing issues such as vomiting, elevated body temperature, and an unpleasant bitter taste after use of visco-gel. The doctor was informed by a second doctor that a patient went to the hospital 23 hours after visco-gel was used on the upper an bottom denture of the patient, with symptoms of "severe poisoning. " additional information has been requested, but is not yet available.
Patient Sequence No: 1, Text Type: D, B5
[20879369]
The visco-gel temporary soft denture liner can be used as a tissue treatment and instructions are available in the dfu. However, the formulation and ratio of liquid to powder has recently changed for this product and it is unknown if the correct ratio was used. Because a serious injury occurred, 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 | 2515379-2014-00057 |
| MDR Report Key | 4118013 |
| Report Source | 01,05 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-01 |
| Date Mfgr Received | 2014-08-01 |
| Date Added to Maude | 2014-09-26 |
| 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 | 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 | VISCO-GEL |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING |
| Product Code | EBI |
| Date Received | 2014-08-28 |
| Catalog Number | 61605002 |
| Lot Number | 1302000703 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-08-28 |