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

Catalog Number 646009

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 340642422
• Report Number: 2515379-2024-00019
• Device Sequence Number: 1
• Product Code: EBC
• UDI-Device Identifier: D0026460091
• UDI-Public: D0026460091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-1976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1