MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-03-03 for THERMAFIL UNK manufactured by Dentsply Tulsa Dental.
[438201]
After a tooth was treated and obturated using thermafil plus, it was noted that infection was present at the apex of the tooth. Also, it was reproted that a continously draining fistula had developed. The patient was subsequently referred to another doctor for further treatment, though the doctor has reportedly been unable to remove the material in order to treat the infection. Further information was requested, though none is available as of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2006-00066 |
| MDR Report Key | 682313 |
| Report Source | 00 |
| Date Received | 2006-03-03 |
| Date of Report | 2006-02-03 |
| Date Mfgr Received | 2006-02-03 |
| Date Added to Maude | 2006-03-09 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR PATRICIAD KIHN |
| Manufacturer Street | 221 W. PHILA ST. STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY TULSA |
| Manufacturer Street | 608 ROLLING HILLS DRIVE |
| Manufacturer City | JOHNSON CITY TN 37604 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMAFIL |
| Generic Name | GUTTA PERCHA OBTURATOR |
| Product Code | EKQ |
| Date Received | 2006-03-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 671581 |
| Manufacturer | DENTSPLY TULSA DENTAL |
| Manufacturer Address | * JOHNSON CITY TN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-03 |