MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-10 for THERMAFIL ENDODONTIC OBTURATOR manufactured by Tulsa Dental Products.
[8809]
Product is used in root canals. After having this device inserted during root canal procedure, client continued to have problems. Client eventually had to have the tooth removed. There is also another person that this atty is aware of who had similar problems. No one is sure what this device does. Endodontists don't use it. Atty would like to know if this device is approved by the fda and the status of this device since there are some lawsuits filed against this firm pertaining to this device. No other dental product of this type contains a metal rod.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000297 |
| MDR Report Key | 11687 |
| Date Received | 1994-02-10 |
| Date of Report | 1993-12-30 |
| Date Added to Maude | 1994-02-24 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMAFIL ENDODONTIC OBTURATOR |
| Product Code | EKQ |
| Date Received | 1994-02-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11687 |
| Manufacturer | TULSA DENTAL PRODUCTS |
| Manufacturer Address | TULSA OK 74136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-10 |