MAUDE Adverse Event Report: DENTSPLY CAULK SUREFIL SDR FLOW; TOOTH SHADE RESIN MATERIAL

Catalog Number 61C001

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

On (b)(4) 2015, a pt called and would not give their name or dentist's name.The pt stated that they think they are having a reaction to a product that the patient's dentist used.The dentist removed seven amalgams and replaced them with surefil sdr and majesty composite material (manufactured by (b)(4)).The next day the pt began to have a salty taste and mucus foam in their mouth.The pt thinks that one of their teeth is 'leaking' and there was a "brown thing" noted in the middle of the molar.The patient's dentist stated that everything was normal.This happened around the end of (b)(6) 2015.The pt also stated that they have no taste buds but just started to get some back.The pt has seen three dentists.A blood test for allergies revealed allergies to milk and mold.The pt was given a copy of the msds to take to the allergist for testing.

Manufacturer Narrative

While it is unk if the device used in this case caused or contributed to the patient's symptoms.It is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: SUREFIL SDR FLOW
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4874691
• MDR Text Key: 19496426
• Report Number: 2515379-2015-00044
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• PMA/PMN Number: K083841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 61C001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MAJESTY COMPOSITE MATERIAL
• Patient Outcome(s): Other