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 06/30/2023

Event Type  Injury  

Event 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.

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.

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
• 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: 17985269
• MDR Text Key: 326269130
• Report Number: 8010638-2023-00029
• Device Sequence Number: 1
• Product Code: KIF
• UDI-Device Identifier: D010606201101
• UDI-Public: D010606201101
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1