MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-27 for SODIUM HYPOCHLORITE 16 OZ. (473 ML) 0011507FG manufactured by Dentsply Caulk.
[46087232]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[46087233]
It was reported that a patient experienced an allergic reaction to sodium hypochlorite. The reported symptoms include pain, swelling and redness from the sub orbital area to the boarder of the mandible. The clinician reported that the patient sought medical attention for the reaction, but did not indicate what the treatment was. The patient's symptoms have improved since treatment.
Patient Sequence No: 1, Text Type: D, B5
[49790628]
Retain product was evaluated and found to be within specification. Also, a dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2016-00015 |
| MDR Report Key | 5684267 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-27 |
| Date of Report | 2016-04-28 |
| Date Mfgr Received | 2016-06-20 |
| Date Added to Maude | 2016-05-27 |
| 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 CAULK |
| Manufacturer Street | 38 W. CLARK AVE. |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODIUM HYPOCHLORITE 16 OZ. (473 ML) |
| Generic Name | CLEANSER, ROOT CANAL |
| Product Code | KJJ |
| Date Received | 2016-05-27 |
| Model Number | NA |
| Catalog Number | 0011507FG |
| Lot Number | 1504151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 W. CLARK AVE. MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-27 |