MAUDE Adverse Event Report: DENTSPLY DETREY GMBH P&BOND ACTIVE STAND.REF.; AGENT, TOOTH BONDING, RESIN

Catalog Number	60667341
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
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 and the lot number was not provided for retained-product testing and/or dhr review.Investigation: no lot available and no returned product.Dentist refuses to give this information.For this, no investigation of return/retain sample can be conducted.
Event or Problem Description
In this event it is reported that p&bond active stand.Ref.That was used in treatment, the dentist observed a chemical burn on the soft tissue of a patient after contact.Duration of exposure, exposure to other irritants (e.G.Etchant), location and severity of burn are unknown.Product could not be returned for analysis.

• Brand Name: P&BOND ACTIVE STAND.REF.
• Common Device Name: 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20535763
• Report Number: 8010638-2024-00011
• Device Sequence Number: 20914069
• Product Code: KLE
• UDI-Device Identifier: D010606673411
• UDI-Public: D010606673411
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: 60667341
• Device Lot Number: 00000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown