MAUDE Adverse Event Report: SEPTODONT INC. ETCH GEL 40%

Lot Number REFUSED TO BE PROVIDED BY USER

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

Patient Problems Burn(s) (1757); Feeding Problem (1850); Pain (1994); Swelling (2091); Sleep Dysfunction (2517)

Event Date 03/11/2016

Event Type  Injury  

Event Description

Spontaneous report.(b)(4).Initial information received by dealer henry schein on (b)(6) 2016.Additional information received by dealer henry schein on 05-apr- 2016 ((b)(4)).Both initial and additional information were received by septodont on (b)(6) 2016.A patient called to report an adverse reaction to suspect product henry schein etch gel that was used during a procedure at the office in (b)(6).Suspect product lot number and expiration date are not provided.The patient stated that, on (b)(6) 2016, suspect product etch gel was used on one of her top molars on the outer side of the tooth.When her novocaine wore off she had excruciating pain and what looked like a clean slice across her gum line.She went back to the dr.Who performed this, dr.(b)(6) who thought it could have been a chemical burn from the gel.She said she noticed that this had occurred recently on a different patient, but then tried to tell the patient that it was a previous infection she must have had.The slice in the patient's gum went down 1/4 inch from her tooth and caused her tooth to wiggle and made eating and sleeping impossible.This patient does have chemical sensitivity as it is and is allergic to certain dies and latex.She said this info is in her file at the office.The patient thought a dental dam should have been used perhaps, but that due to her allergy maybe it was not.The patient ended up with a large lump on her face as a result of the trauma in her mouth as well as some white scabbing on her gums.Dr.(b)(6) is the point of contact in this matter and is the boss of the dr.Who performed the procedure.The patient came in on (b)(6) 2016 for a followup and the office could not provide any detail on the matter due to confidentiality.Henry schein has asked for the lot number from the office and they keep directing to dr.(b)(6) who is not at the location.They refuse to give any more information at the location that it actually happened at.When speaking with the receptionist the receptionist never gives phone to dr.(b)(6) suspect product lot number and expiration date are not provided and refused to be provided by user facility.Sender's comments: causality assessment on (b)(6) 2016 by (b)(6) on initial information received on (b)(6) 2016 and additional information received on 05-apr-2016: seriousness: overall serious (reasons: the extent of gingival injury and loose tooth reported evaluated as medically important; reported eating and sleeping impossible evaluated as persistent or significant disability/incapacity as events occurred for prolonged period since event start date).Expectedness: pain: unexpected usa, gingival disorder: unexpected usa, chemical injury: expected usa, gingival injury: unexpected usa, loose tooth: unexpected usa, eating disorder: unexpected usa, insomnia: unexpected usa, swelling face: unexpected usa, scab: unexpected usa.Causality.Latency - possible.Recognized association - only for chemical injury.Alternative etiology - etch gel 40% contains 40% phosphoric acid in a gel form (corrosive), some precautions should be applied before using as mentioned in manual of device (specify warnings to avoid contact with oral soft tissue).The customer herself reported that suspect etch gel was used on one of her top molars on the outer side of the tooth and was not confirmed by the dentist.Contact with etch gel 40% known to be corrosive might lead to the occurrence of the events and may cause tissue damage.Therefore, the company considered this incident as serious and possibly related to etch gel 40%.Dechallenge - na.Rechallenge - na.Concluded causality: possible.

Manufacturer Narrative

Manufacturer investigation results received on 27-jun-2016: no lot number was provided for this complaint.No lot number nor expiration date information could be identified from the returned product.In the absence of the exact batch involved in the reported incident, the manufacturer was able to determine the suspect lot numbers involved based on the purchase history of the suspect product sold by the dealer to the reporting dentist within the one year prior to the incident: h006349a, h005388a, h005475a, h004784a, h005020a and h003501a.The testing results of these lots were reviewed and all lots passed testing and inspection before release.The returned sample was examined and was tested for acidity; analytical results found the acidity of the returned product was within specification.Product quality defect was not confirmed.No corrective action is required.As stated in the instructions for use document (ifu) enclosed with the suspect etch gel, the product contains phosphoric acid, which is corrosive and can cause tissue damage.Precautions should be taken to avoid placing acid etch gel on oral soft tissues (i.E.Isolation of the tooth using a rubber dam is highly recommended).For further information on the application instructions, warnings and storage conditions of the product, please consult with the ifu that accompanies with the product.

Event Description

Follow-up report #1.Causality assessment done on 22-jul-2016.Additional information received on 27-jun-2016 from the manufacturer investigation report does not change the previous assessment.

• Brand Name: ETCH GEL 40%
• Type of Device: ETCH GEL 40%
• Manufacturer (Section D): SEPTODONT INC.; 418s taylor ave.; louisville CO 80027
• Manufacturer Contact: steve rudulph ; 416 south taylor ave.; louisville, CO 80027 ; 3036657535
• MDR Report Key: 5593406
• MDR Text Key: 43155189
• Report Number: 0001721729-2016-00001
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K030743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

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: Dentist
• Device Lot Number: REFUSED TO BE PROVIDED BY USER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 45 YR