MAUDE Adverse Event Report: DSHEALTHCARE INC. SODIUM HYPOCHLORITE SOLUTION; ROOT CANAL CLEASNER

Catalog Number 0011507FG

Device Problem Use of Device Problem (1670)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 09/24/2014

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: SODIUM HYPOCHLORITE SOLUTION
• Type of Device: ROOT CANAL CLEASNER
• Manufacturer (Section D): DSHEALTHCARE INC.; hackensack NJ
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4210401
• MDR Text Key: 5039959
• Report Number: 2515379-2014-00069
• Device Sequence Number: 1
• Product Code: KJJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-ADMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0011507FG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other