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

Catalog Number 60620110

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 01/28/2014

Event Type  Injury  

Event Description

In this event it was reported that a patient experienced an allergic reaction after using ah plus.The symptoms reported were swollen lips and hives.The patient was administered cortisone to combat the reaction.

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 dependant upon the severity of the individual allergic response and subsequent exposure of the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is not available for evaluation.However, the lot number was provided for retain product testing.Retain-product was evaluated and found to be within specification.

• Brand Name: AH PLUS ROOT CANAL SEALER
• Type of Device: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): DENTSPLY DETREY GMBH; konstanz ; GM
• Manufacturer Contact: helen lewis ; susquehanna commerce center w.; 221 w. philidelphia st. ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3767460
• MDR Text Key: 4373055
• Report Number: 8010638-2014-00003
• 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: 03/13/2014

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: 03/31/2015
• Device Catalogue Number: 60620110
• Device Lot Number: 13030000872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/14/2014
• 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): Other