MAUDE Adverse Event Report: HYGENIC ENDO-ICE REFRIGERANT SPRAY; PULP TESTER

Model Number	H05032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Sore Throat (2396); Cough (4457); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer stated that she visited the dentist's office on (b)(6) 2021.When doctor was doing procedure, the instrument that he was using had endo-ice on it.(the patient did not see the instrument being sprayed; however, this is what was told to her).When the instrument was placed on her tooth, some of the spray dripped down her throat.She did swallow it.She stated that it had a horrible taste and her saliva was foamy when she spit it out into a cup.The office did give her water to drink afterwards.The patient now has a lot of mucus and a very sore throat, chest pains, her tongue is sore, shortness of breath, fatigue, and a cough.She said that she had none of these symptoms before this incident.She was advised to go to her doctor for evaluation by dentist office.The patient was contacted directly on (b)(6) 2021.She indicated that she swallowed 3 drops of endo- ice that dripped into her throat from the cotton ball.Three days after the incident she went to the emergency room for evaluation.The emergency room doctor advised that she contact a gi doctor.
Additional Manufacturer Narrative
Health effect - clinical code 4581 was used for this adverse event.The customer was experiencing excess mucous.The can of endo-ice associated with this adverse event was not available from the customer because the dental office continued to use the product until empty and threw away the can.As of 08/26/2021, no other adverse events have been reported for this product from this dental office.
Event or Problem Description
Additional information: the dentist's office was contacted on (b)(6) 2021 regarding the complaint.The dentist office confirmed that endo-ice was used and that it was sprayed on a pellet in the back of the room away from the patient.According to the dentist notes, the patient came in for evaluation of her lower right area.Endo-ice was sprayed on a cotton pellet at the back of the room and then placed on the tooth.The patient seemed to have a reaction to the endo-ice and stated that the fumes/taste burned her throat.No further cold treatment was performed by the dentist.The dentist did provide water and mouthwash to the patient.The dental office indicated that the patient did not mention anything about drips of endo-ice in her throat and that only fumes/tastes were mentioned.

• Brand Name: HYGENIC ENDO-ICE REFRIGERANT SPRAY
• Common Device Name: PULP TESTER
• MDR Report Key: 12134552
• Report Number: 2416455-2021-00002
• Device Sequence Number: 14466234
• Product Code: EAT
• UDI-Device Identifier: D661H050320
• UDI-Public: D661H050320
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H05032
• Device Catalogue Number: H05032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other