MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-18 for DUAL CHAMBER SYRINGE SEALER RIBBON manufactured by Tulsa Dental Products Llc.
[105804417]
Because this event resulted in a serious injury, it is reportable per 21cfr part 803. Retain product was tested and found to be within specification. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
[105804418]
It was reported that a dentist overfilled a patient's root canal with dual chamber syringe sealer. The patient had pain so the dentist extracted the patient's tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320721-2018-00020 |
| MDR Report Key | 7440087 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2018-04-18 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY DETREY GMBH |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ, 78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL CHAMBER SYRINGE SEALER |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2018-04-18 |
| Model Number | NA |
| Catalog Number | RIBBON |
| Lot Number | 1611000644 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TULSA DENTAL PRODUCTS LLC |
| Manufacturer Address | 608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-04-18 |