MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-22 for COMFORT LINING THERMOPLASTIC DENTURE ADHESIVE UNK manufactured by Unk.
[39116769]
Found a product claiming to be similar to plough-schering's former "cushion grip" which has been discontinued for unk reason. Name of this product is comfort lining thermal plastic denture adhesive. Product claims to be fda approved and/or fda certified on various web sites and forums. Fda info for product/mfr/distributor cannot be found in searching fda database(s). Claims made by product mfr/distributor seem to be false and many consumers experiencing a variety of issues failure of performance. Ingredients of product remain unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060494 |
| MDR Report Key | 5460858 |
| Date Received | 2016-02-22 |
| Date of Report | 2016-02-22 |
| Date of Event | 2016-02-22 |
| Date Added to Maude | 2016-02-25 |
| 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 |
| 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 THERMOPLASTIC DENTURE ADHESIVE |
| Generic Name | THERMOPLASTIC DENTURE ADHESIVE |
| Product Code | KOO |
| Date Received | 2016-02-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NONE PROVIDED |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-22 |