MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for COE-SOFT manufactured by Gcamerica Inc..
[177355965]
My dentist dr (b)(6) relined my acrylic denture with a product called coe-soft. The chemical out gasing of the material was horrific and left a horrible taste in my mouth. A week later the product is still out gasing in my mouth. This chemical is getting into my blood stream. This is a very unhealthy situation. My dentist gave me the instruction sheet that accompanies the product. The print is so small that my dentist's receptionist could not read it. I also cannot read it. Mfrs should not be allowed to include printed directions that cannot be easily read. This product should not be on the market as it impinges on one's health - swallowing these chemicals is unhealthy. Coe-soft is a product of gcamerica. The phone number my dentist provided from them is (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092630 |
| MDR Report Key | 9646834 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-21 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COE-SOFT |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2020-01-29 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GCAMERICA INC. |
| Product Code | --- |
| Date Received | 2020-01-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-01-29 |