MAUDE Adverse Event Report: DENTSPLY DETREY GMBH AH PLUS EXPORT 3ML CHINA; RESIN, ROOT CANAL FILLING

Catalog Number 606.20.113

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/17/2024

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.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported that ah plus export 3ml caused a burning sensation on the skin when using the product.Get better after discontinuation.It is unclear how exposure to the product and its discontinuation occurred.In fact, very little information is shared about the patient, the treatment, and the event.In light of the information provided, it is not possible to come to a conclusion.

Manufacturer Narrative

Investigation: the retained sample was tested in the laboratory.The identity of the material of the tubes (amin & epoxid ) corresponds to the reference samples.The consistency and the setting behavior of the material are okay.The assessment is not applicable to this complaint.Dhr the dhr of the complained batch was checked.There were no abnormalities in the dhr.

• Brand Name: AH PLUS EXPORT 3ML CHINA
• Type of Device: RESIN, ROOT CANAL FILLING
• 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: 18788703
• MDR Text Key: 336338762
• Report Number: 8010638-2024-00001
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/24/2024

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 Catalogue Number: 606.20.113
• Device Lot Number: 20231120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/26/2024
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• Type of Device Usage: A
• Patient Sequence Number: 1