MAUDE Adverse Event Report: DENTSPLY DETREY GMBH FIX ADHESIVE LIQUID; AGENT, TOOTH BONDING, RESIN

Catalog Number 61601004

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 09/09/2014

Event Type  Injury  

Event Description

In this event, a patient reported that she had experienced a swollen mucosa, heart problems and dizziness after a dental procedure that incorporated the use of fix adhesive liquid.The dentist was contacted and reported that they did not see any signs of a swollen mucosa during follow up several hours after the treatment or during a subsequent follow up the day after treatment.The dentist reported that the treatment of the impression tray with fix adhesive liquid was done by a dental assistant and there is a possibility of the contact of a larger quantity of liquid with the intraoral mucosa.

Manufacturer Narrative

While it is unknown 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 consequence 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 evaluation and the lot number was not provided for retained-product testing and/or dhr review.Please note that while this product is not sold in the us, it is considered similar to products that are when taking into account composition and indications for use.

• Brand Name: FIX ADHESIVE LIQUID
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): DENTSPLY DETREY GMBH; konstanz ; GM
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr. w; 221 w. philadelphia st., ste. 60; york, OH ; 7178457511
• MDR Report Key: 4193854
• MDR Text Key: 5097747
• Report Number: 8010638-2014-00007
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/09/2014

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 Catalogue Number: 61601004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/11/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other