MAUDE Adverse Event Report: NUSMILE LTD. AVALON BIOMED NEOSEALER FLO; MTA2.3 ROOT & PULP MATERIALS

Catalog Number ANSPK

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

On october 28, 2022 in a complaint investigation follow-up call the clinician (and endodontist) who performed the root canal procedure confirmed the patient had developed a rash throughout their body and that medical intervention in the form of an oral steroid was provided to help clear up the rash.The also clinician confirmed that the patient showed no signs of distress.Several instruments and chemicals where used in the treatment, neosealer flo being one.While these other chemicals may have caused the rash, neosealer flo could not be entirely dismissed as allergic responses to many dental materials are possible.While no impairment to the function or permanent damage of the body occurred, the manufacturer has chosen to take a proactive response to this case and report in compliance with 21 cfr part 803.There has never been a previous report of allergic responses regarding this product or any other products with similar chemistry from the manufacturer.

Event Description

The office staff of doctor (and endodontist) of a patient that had undergone a root canal procedure reported the patient developed a rash after the procedure was completed.Neosealer flo was used as a root canal sealer in the course of treatment.Neosealer flo cannot be confirmed as the cause for the reaction, nor can it be entirely ruled out as multiple items were used in this procedure.

• Brand Name: AVALON BIOMED NEOSEALER FLO
• Type of Device: MTA2.3 ROOT & PULP MATERIALS
• Manufacturer (Section D): NUSMILE LTD.; 3315 w 12th street; houston TX 77008
• Manufacturer (Section G): NUSMILE; 3315 w 12th street; houston TX 77008
• Manufacturer Contact: jonathan soriano ; 3315 w 12th street; houston, TX 77008
• MDR Report Key: 15873192
• MDR Text Key: 304416702
• Report Number: 3006444232-2022-00001
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ANSPK
• Device Lot Number: 2022072003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male