MAUDE Adverse Event Report: DENTSPLY DETREY GMBH FIX ADHESIVE BOTTLE 30 ML; AGENT, TOOTH BONDING, RESIN

Catalog Number 616.01.004

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Cough (4457); Stomatitis (4489); Blister (4537)

Event Date 06/28/2022

Event Type  Injury  

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 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 evaluation and the lot number was not provided for retained-product testing and/or dhr review.Additional information requested and will be submitted as it becomes available.

Event Description

In this event it is reported that fix adhesive bottle 30 ml that a patient experienced a possible allergic reaction to the use of fix adhesive.Patient reported that had extensive contact with this "adhesive varnish" in her mouth, mucosa, teeth, tongue during a dental impression taking.There was no other treatment that day.Reported to experience strong burning in the mouth/teeth, burning of the airways and cough, initially also loss of taste, small blisters in the mouth and shortness of breath.Patient reported to having to take pain killers.Outcome is unknown as of this mdr.Additional information requested and is pending.

Manufacturer Narrative

The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: FIX ADHESIVE BOTTLE 30 ML
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15121204
• MDR Text Key: 296768305
• Report Number: 8010638-2022-00014
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 616.01.004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/26/2022
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female