MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-06 for SODIUM HYPOCHLORITE 0011507FG manufactured by Dentsply Caulk.
[5446095]
In this event it was reported that after use of sodium hypochlorite during a root canal therapy procedure, a pt expressed that they were in pain. The next day, the pt returned to the dentist and their face was swollen from the jaw down to the neck area. The pts' tooth had to be extracted.
Patient Sequence No: 1, Text Type: D, B5
[12807799]
The dr thought that the pt may have experienced an allergic reaction to the sodium hypochlorite. However, the symptoms described are more consistent with complications arising from the sodium hypochlorite being extruded beyond the root apex. Due to the permanent loss of the tooth, this event is reportable per 21 cfr part 803. The device is available for eval, though has not been returned as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2015-00002 |
| MDR Report Key | 4495743 |
| Report Source | 05 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-06 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2015-01-06 |
| Date Added to Maude | 2015-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST, STE 60 INCSUSQUEHANNA COMMERCE CTR W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODIUM HYPOCHLORITE |
| Generic Name | CLEANSER, ROOT CANAL |
| Product Code | KJJ |
| Date Received | 2015-02-06 |
| Catalog Number | 0011507FG |
| Lot Number | 131218 |
| Device Expiration Date | 2014-12-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | MILFORD DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-02-06 |