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

Catalog Number 606.20.115

Device Problem Patient-Device Incompatibility (2682)

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

Event Description

It was reported that a patient experienced high blood pressure that began approximately one hour after having root canal treatment with ah plus jet.The doctor removed the material and the patient recovered.The doctor believes the patient may have an allergy to the product.The patient is undergoing allergy testing, but the results are not yet available.

• 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
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz, 78467 ; GM 78467
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7659755
• MDR Text Key: 113062218
• Report Number: 8010638-2018-00007
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606.20.115
• Device Lot Number: 1603000602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other