MAUDE Adverse Event Report: AH TEMP; RESIN, ROOT CANAL FILLING

Catalog Number 606.20.123

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Increased Sensitivity (2065); Discomfort (2330)

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 has not been returned 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 ah temp.The patient had redness in face, sensitivity, feeling sore, high level of discomfort.Patient went back to dentist for removal of ah temp, cleaning of canal and placement of other temp material.Patient still have some symptoms.

Manufacturer Narrative

The device was evaluated and found to be within specification.Retain device was also evaluated and found to be within specification.Also, a dhr review was conducted with no discrepancies noted.

• Brand Name: AH TEMP
• Type of Device: RESIN, ROOT CANAL FILLING
• MDR Report Key: 11109186
• MDR Text Key: 224811639
• Report Number: 8010638-2020-00008
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606.20.123
• Device Lot Number: 1901000591
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other