MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-28 for COMFORT LINING DENTURE, ADHESIVE manufactured by Comfort Lining.
[74299643]
I bought comfort lining which is a denture adhesive. They do not label their ingredients that they are using and will tell me what is in the product. I don't know if i am using anything that is carcinogenic or not. Is the product over-the-counter: yes. How was it taken or used: topical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069476 |
| MDR Report Key | 6537934 |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-28 |
| Date Added to Maude | 2017-05-02 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMFORT LINING DENTURE, ADHESIVE |
| Generic Name | COMFORT LINING DENTURE, ADHESIVE |
| Product Code | KOO |
| Date Received | 2017-04-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMFORT LINING |
| Manufacturer Address | PO BOX 2553 PONTE VEDRA FL 32004 US 32004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-28 |