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

Catalog Number 606.20.118

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/25/2020

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 was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

It was reported that a patient experienced an allergic reaction ah plus jet.The patient received medication from her doctor and has fully recovered.

• Brand Name: AH PLUS JET
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• MDR Report Key: 10602843
• MDR Text Key: 209137226
• Report Number: 8010638-2020-00006
• 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
• Report Date: 09/29/2020

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: 03/31/2021
• Device Catalogue Number: 606.20.118
• Device Lot Number: 1904000468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR