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	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event it is reported that ah plus export 3ml china that was used in treatment on a patient caused gum redness and swelling to the patient.The area was immediately rinsed with water and refilled.Further information requested.
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
We received the following information by the ds china: the sales colleague has confirmed with the head nurse that the incident did not actually occur.Please void this case.This follow up report is to correct this event to a non-reportable.This report was submitted in error.Please disregard the initial report.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19546849
• Report Number: 8010638-2024-00006
• Device Sequence Number: 6711354
• 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): 07/08/2024

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: 2404000117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/11/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown