MAUDE Adverse Event Report: DENTSPLY CAULK TPH SPECTRA ST FLOW; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 642526

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Tissue Breakdown (2681)

Event Type  Injury  

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 is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a patient experienced an allergic reaction to the use of tph spectra st flow.The patient had sores and blisters under her tongue and lips.

Manufacturer Narrative

The material sent by the customer was too little, so the retain sample was checked and found within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: TPH SPECTRA ST FLOW
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 11256714
• MDR Text Key: 229577343
• Report Number: 2515379-2020-00013
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• PMA/PMN Number: K182288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 642526
• Device Lot Number: 2002000108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 11/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other