MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-27 for SODIUM HYPOCHLORITE SOLUTION 0011507FG manufactured by Dshealthcare Inc..
[5039959]
In this event it was reported that a patient had inadvertently ingested a small amount of sodium hydrochloride during a dental procedure. The patient immediately experienced a burning sensation. The patient was advised to drink milk or water and to seek medical attention. After rinsing with water, the patient felt better and did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[12450753]
Review of the package labeling and dfu determined that ther are appropriate warnings and precautions. Sodium hypochlorite is a hazardous material that if ingested, could potentially interact with stomach acids, releasing chlorine gas. Therefore, if ingestion were to recur, it could necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function. This event, therefore, is reportable 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 | 2515379-2014-00069 |
| MDR Report Key | 4210401 |
| Report Source | 05 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-24 |
| Date Mfgr Received | 2014-09-25 |
| Date Added to Maude | 2014-10-30 |
| 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 SUSQUEHANNA COMMERCE CENTER 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 SOLUTION |
| Generic Name | ROOT CANAL CLEASNER |
| Product Code | KJJ |
| Date Received | 2014-10-27 |
| 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 | 2014-10-27 |