MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-21 for SODIUM HYDROCHLORITE SOLUTION 6% 0011507FG manufactured by Dshealthcare Inc..
[3894932]
In this event a dentist called stated that a patient had inadvertently rinsed their mouth out with sodium hypochlorite thinking it was water. The patient immediately experienced a burning sensation. Dentsply advised the dentist that the patient should rinse with water, drink one glass of water, and seek immediate medical attention. The patient did rinse with water and drank a glass of water. The doctor then stated they were going to contact poison control. The doctor refused to provide any further information.
Patient Sequence No: 1, Text Type: D, B5
[11341219]
Review of the package labelings and dfu determined that there are appropriate warnings and precautions. Sodium hypochlorite is a hazardous material that if ingested, could potentially interact with stomach acids, releasing chlorine gas. Although the event outcome is unknown, it is presumed that the patient sought medical attention. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2013-00064 |
| MDR Report Key | 3431552 |
| Report Source | 05 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-09-23 |
| Date of Event | 2013-09-23 |
| Date Mfgr Received | 2013-09-23 |
| Date Added to Maude | 2013-10-29 |
| 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 | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARKE 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 HYDROCHLORITE SOLUTION 6% |
| Product Code | KJJ |
| Date Received | 2013-10-21 |
| Catalog Number | 0011507FG |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSHEALTHCARE INC. |
| Manufacturer Address | HACKENSACK NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-10-21 |