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

Catalog Number 606.20.118

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

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 swelling after the use of ah plus jet.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: AH PLUS JET
• Type of Device: RESIN, ROOT CANAL FILLING
• MDR Report Key: 11510179
• MDR Text Key: 240554474
• Report Number: 8010638-2021-00002
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• PMA/PMN Number: K960548
• 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: 09/09/2021

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 Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 606.20.118
• Device Lot Number: 2101000819
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other