MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 1996-11-06 for COE-SOT UNK manufactured by Gc America Inc..
[15686056]
The pt had her dentures lined with product for the first time on august 4,1991. The day after she developed a blister and was told by her dr that there was nothing wrong. She had the second lining done on august 31 because she wanted a new top plate and a partial bottom plate and her dentist said he needed to have a good fit. She had it done, left town and the next day experienced pain and a swollen mouth. She saw her dentist on an emergency basis on 9/3 who told her she had pagent's disease and recommended she see her dr. Her dr sent her to a neurologist who wrote in a letter to her original dr and i quote:" it sounds to me like this lady had some form of chemical reaction to the acrylic used in fitting her dentures and as a result sustained significant tissue injury. There is no question she may have injury to the nerve endings. " she went to a dentist in the u. S. On her own because she still had a lot of pain and was told she had a reaction to the chemicals in the product. Her gums are severely damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-1996-26371 |
| MDR Report Key | 46147 |
| Report Source | 01 |
| Date Received | 1996-11-04 |
| Date of Report | 1996-11-04 |
| Date of Event | 1991-09-01 |
| Report Date | 1996-11-04 |
| Date Mfgr Received | 1996-10-04 |
| Date Added to Maude | 1996-11-05 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | COE-SOT |
| Generic Name | SOFT DENTURE LINING |
| Product Code | EBP |
| Date Received | 1996-11-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 46996 |
| Manufacturer | GC AMERICA INC. |
| Manufacturer Address | 3737 WEST 127TH ST CHICAGO IL 60658 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-04 |