MAUDE Adverse Event Report: SEPTODONT ISODAN

Model Number 01S0100

Device Problem Device Emits Odor (1425)

Patient Problems Dizziness (2194); Discomfort (2330); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688)

Event Date 03/08/2014

Event Type  Injury  

Manufacturer Narrative

According to the statement of claim, it is alleged that the defendant registered dental hygienist have little or no experience with the application and the use of isodan.At the time of this initial report, the batch number and expiration date used on the patient are not available, and no information about the availability of the device used on the patient for evaluation is available.A search in the global safety database confirms that is the first incident of this kind for isodan; no similar report was received previously.Since the incident occurred solely in (b)(6), no importer of the product into the united states was involved.Accordingly, no importer's report is being submitted.

Event Description

Spontaneous report.Legal case; allegations not yet verified by defendants.Local reference # (b)(4).Initial information (notice of action and statement of claim) were filed in the (b)(6), and were received by septodont legal counsel in (b)(4) on 27-oct-2016: the case involved the product isodan manufactured by septodont, and which administered by a hygienist in 2014.Statement of claim relevant to the medical device incident are listed below: on (b)(6) 2014, the plaintiff attended [dental clinic, dental clinic name redacted] to seek treatment for sensitive teeth.[name of operator redacted]'s application of isodan subjected the plaintiff to a foul odour and taste, as well as a stinging sensation in her mouth and on her tongue.As a result of the foregoing, the plaintiff has suffered a permanent deterioration of her health.The plaintiff has suffered enduring symptoms including chronic acid reflux, tooth damage, recurring facial lesions, stomach discomfort, disrupted sleep, and light headedness.The plaintiff is a female of unspecified age.The plaintiff's medical history, concomitant treatment from the received statement of claim.It is also noted in the statement of claim that: in the course of treating the plaintiff, defendant registered dental hygienist, applied a product new to her experience, isodan, to the plaintiff's teeth.The defendant registered dental hygienist professed at the time to have little or no experience with the application and use of this product, and gave only cursory examination to the instructions before using it on the plaintiff.Medical review performed by septodont based on the allegations described in the statement of claim on (b)(6) 2016: seriousness: serious (permanent deterioration of the plaintiff's health claimed).Listedness/expectedness: general physical health deterioration: unexpected us/(b)(4); gastrooesophageal reflux disease: unexpected us/(b)(4); tooth disorder: unexpected us/(b)(4); skin lesion: unexpected us/(b)(4); abdominal discomfort: unexpected us/(b)(4); poor quality sleep: unexpected us/(b)(4); headache: unexpected us/(b)(4); glossodynia: unexpected us/(b)(4); oral pain: unexpected us/(b)(4); product odour abnormal: unexpected us/(b)(4); product taste abnormal: unexpected us/(b)(4).Causality: latency: unknown except for the reaction which occurred the same day of application.Recognized association: no.Analysis: the time of onset of foul odour and taste, as well as a stinging sensation in her mouth and on her tongue is unknown (perhaps these reactions occurred the same day of the application product but the date of reaction is unknown).Apparently, it was the first time that the hygienist applied the product isodan.The indication of the product is to treat hypersensitive teeth.No information of the preexisting state of the treated tooth is provided.The aforementioned symptoms qualified as permanent deterioration of the patient's health are not expected to occur with such product.No information of the previous condition of the patient is provided to assess the causal relationship with the product.Dechallenge: n/a; rechallenge: n/a.Concluded causality who: not assessable.

Manufacturer Narrative

According to the status update from septodont general counsel on 05-jun-2017, no updates has been received since the notice of action was received by septodont on 27-oct-2016 and no further information is expected.No information about the availability of the device provided in received notice of claim.Furthermore, no device has been returned to septodont for evaluation at the time of this follow-up and final report.The actual suspect device has not been returned and no lot information is available.A comprehensive evaluation of the reported incident cannot be conducted given the limited information available.In conclusion, the reported incident is considered isolated at this time.No root cause can be identified and no corrective action is therefore required.No root cause can be identified from this incident.This is the first incident of this kind for isodan; no similar report was received previously.

Event Description

Status update from septodont general counsel on 05-jun-2017: no updates available has been received since the notice of action was received by septodont on 27-oct-2016.No further information is expected.Medical review performed by septodont on 02-aug-2017 based on additional information received on 05-jun-2017: taking into account the latest information, the previous analysis and causality assessment do not change.In addition, literature describes the association between gastroesophageal reflux disease and tooth erosion [1].Teeth exposed to acid attacks due to gastric and duodenal regurgitation combined with a decrease in normal protective mechanisms of saliva leading to the oral manifestations such as tooth disorder, sour taste, halitosis, etc.[2].Therefore, without additional information, the causal relationship between the suspect product and the adverse events is not assessable as it is possible that the pre-existing condition of the patient may have led to the reported claims.Concluded causality who: not assessable.References: [1] ranjitkar s, kaidonis ja, smales rj, "gastroesophageal reflux disease and tooth erosion," international journal of dentistry, vol.2012, article id 479850, 10 pages, 2012.Doi:10.1155/2012/479850 [2] ibid.

• Brand Name: ISODAN
• Type of Device: ISODAN
• Manufacturer (Section D): SEPTODONT; 58, rue du pont de creteil; saint maur des fosses, cedex 94107 ; FR 94107
• Manufacturer Contact: 58, rue du pont de creteil; saint maur des fosses, cedex 94107
• MDR Report Key: 6119098
• MDR Text Key: 60624763
• Report Number: 9610964-2016-00002
• Device Sequence Number: 1
• Product Code: KLE
• UDI-Device Identifier: 03760140703304
• UDI-Public: 03760140703304
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Model Number: 01S0100
• Device Catalogue Number: 01S0100
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability