MAUDE Adverse Event Report: DENTSPLY DETREY-DEDENT AH PLUS JET; ROOT CANAL FILLING RESIN

Catalog Number 60620115

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that a patient experienced an allergic reaction after treatment with ah plus jet.The symptoms reported included swelling, rash and pain.The patient was treated with cortisone to combat the symptoms.

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.

• Brand Name: AH PLUS JET
• Type of Device: ROOT CANAL FILLING RESIN
• Manufacturer (Section D): DENTSPLY DETREY-DEDENT; konstanz ; GM
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st; ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4746077
• MDR Text Key: 5769869
• Report Number: 8010638-2015-00004
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/02/2015

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 Expiration Date: 01/31/2016
• Device Catalogue Number: 60620115
• Device Lot Number: 14060000459
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention