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

Catalog Number	606.20.113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that during use of ah plus export 3ml china in root canal filling; during the filling process the patient reported gingival itching at the filling place, and the symptoms gradually intensified.There was no relief after 5 minutes of observation.The filling material in the root canal was removed, and the normal saline and hydrogen peroxide were washed alternately.The patient reported gradual remission of symptoms.Suspected root filling material allergy.Applied filling material to the left hand of the patient, gradually feel the itching aggravated, and then rinse away.Zinc oxide temporarily sealed, a week of follow-up, replace with other materials.
Additional 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.
Additional Manufacturer Narrative
Investigation results: retain: retained sample was examined.Results are within specification and can be found in the attachment.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
• Common Device Name: 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: 17985269
• Report Number: 8010638-2023-00029
• Device Sequence Number: 12568196
• Product Code: KIF
• UDI-Device Identifier: D010606201101
• UDI-Public: D010606201101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 2203000066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown