MAUDE Adverse Event Report: SEPTODONT SAS BIOROOT RCS

Lot Number B27456

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's initial comments: based on the first data available, the report described an anaphylactic reaction with the use of bioroot rcs following the procedure of root canal filling.In addition, the dentist used septanest to perform the procedure.After having done allergy tests to septanest and bioroot, the patient would be positive only to the liquid component of bioroot and so to the mix liquid-powder.Pending quality investigations, an allergy to the product is considered as the root cause.Based on the preliminary analysis, pending quality investigation and additional information, no capa is required.Hypersensitivity is mentioned in the notice of the product.Manufacturer's final comments: allergy tests to septanest and bioroot were done and the patient was positive only to the liquid component of bioroot and so to the mix liquid-powder.No quality investigation was carried out.Therefore, allergy to the product is considered as the main root cause.In addition, misuse can be excluded as a possible root cause.Allergy tests to septanest and bioroot were performed.No capa is required.Allergy tests to septanest and bioroot were performed misuse can be excluded as a possible root cause.No capa is required.No quality investigation carried out.Misuse can be excluded as a possible root cause.No capa is required.

Event Description

Spontaneous report, from france.Local reference: #(b)(4).Quality complaint was opened: references (b)(4).This initial serious case report was received on 29-sep-2022 from the dentist by phone.Follow-up 1 was received on 07-oct-2022 from the sale representative by email.Follow-up 2 was received on 14-nov-2022 from the dentist by email.All information were processed together.The report described a stage 3 anaphylactic reaction with the suspected medical device bioroot rcs in a 80-year-old female patient following the procedure of root canal filling on tooth #26.The patient is non-smoker and has a medical history of cva (cerebrovascular accident) which happened in (b)(6) 2021.The patient received a similar product in the past without any complications.The patient was not anxious before dental treatment.On (b)(6) 2022, 5 hours after administration, the patient experienced a stage 3 anaphylactic reaction following a root canal filling of permanent and vital tooth #26.It was reported that the dentist used as concomitant drug the local anesthetic septanest (articaine hydrochloride/ epinephrine bitartrate) to perform the procedure.Long-term treatment included (as concomitant drugs): aspirine cardio 100mg (acetylsalicylic acid) for the treatment of cva at the dosage of 1 tablet every morning since (b)(6) 2021 and plendil senior 25 mg (felodipine) for the treatment of hypertension at the dosage of 1 tablet every morning since (b)(6) 2021.On (b)(6) 2022, the patient underwent the following tests: skin prick test to septanest (articaine / epinephrine) was found to be negative.Skin test to bioroot rcs powder was found to be negative.Skin test to bioroot rcs liquid was found to be positive.Skin test to bioroot rcs powder + liquid was found to be positive.Other information of product: batch number: b27456, expiry date dec-2022.This case is serious due to seriousness criteria "other medically important information" as the reaction is part of the ime list.Manufacturer's initial comments: based on the first data available, the report described an anaphylactic reaction with the use of bioroot rcs following the procedure of root canal filling.In addition, the dentist used septanest to perform the procedure.After having done allergy tests to septanest and bioroot, the patient would be positive only to the liquid component of bioroot and so to the mix liquid-powder.Pending quality investigations, an allergy to the product is considered as the root cause.Based on the preliminary analysis, pending quality investigation and additional information, no capa is required.Hypersensitivity is mentioned in the notice of the product.Manufacturer's final comments: allergy tests to septanest and bioroot were done and the patient was positive only to the liquid component of bioroot and so to the mix liquid-powder.No quality investigation was carried out.Therefore, allergy to the product is considered as the main root cause.In addition, misuse can be excluded as a possible root cause.Allergy tests to septanest and bioroot were performed.No capa is required.Allergy tests to septanest and bioroot were performed misuse can be excluded as a possible root cause.No capa is required.No quality investigation carried out.Misuse can be excluded as a possible root cause.No capa is required.

• Brand Name: BIOROOT RCS
• Type of Device: BIOROOT RCS
• Manufacturer (Section D): SEPTODONT SAS; 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94100 ; FR 94100
• Manufacturer (Section G): SEPTODONT S.A.S.; 58, rue du pont de creteil; saint maur, cedex val-de-marne 94100
• Manufacturer Contact: 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94100
• MDR Report Key: 17633811
• MDR Text Key: 322087565
• Report Number: 9610964-2023-00016
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/28/2023

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
• Device Operator: Health Professional
• Device Lot Number: B27456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: #1: SEPTANESTBATCH: UNKNOWNROUTE: DENTAL; #1:ASPIRINE CARDIO 100MGBATCH: UNKROUTE: ORAL; #3: PLENDIL SENIOR 25 MGBATCH: UNKROUTE: ORAL
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female