MAUDE Adverse Event Report: DENTSPLY LLC TOOTH CONDITIONER PKG; SEALANT, PIT AND FISSURE, AND CONDITIONER

Catalog Number	646009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that tooth conditioner was dispensed excessively in a patient's mouth covering pallet and throat.The tooth conditioner was rinsed thoroughly.Patient consulted pharmacy and they recommended benadryl and maalox.Material left over was thrown away.Further information requested.
Additional Manufacturer Narrative
Product not received at investigation site and the lot# is unknown.Therefore a dhr cannot be done.Complaint will be reopened if suspect product or investigation result arrives per (b)(4).

• Brand Name: TOOTH CONDITIONER PKG
• Common Device Name: SEALANT, PIT AND FISSURE, AND CONDITIONER
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19148582
• Report Number: 2515379-2024-00019
• Device Sequence Number: 7443853
• Product Code: EBC
• UDI-Device Identifier: D0026460091
• UDI-Public: D0026460091
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-1976
• 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,Followup
• Report Date (Section B): 06/11/2024

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: 646009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown