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

Catalog Number 60620110

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Edema (1820)

Event Date 01/25/2014

Event Type  Injury  

Event Description

In this event it was reported that after use of ah plus, a patient developed angioedema in their face, neck and breast.There is no information regarding the duration of the reaction, or whether any medical intervention was required as a result.

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 is reportable per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: AH PLUS ROOT CANAL SEALER
• Type of Device: ROOT CANAL FILLING RESIN
• Manufacturer (Section D): DENTSPLY DETREY GMBH; konstanz ; GM
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4009391
• MDR Text Key: 4706211
• Report Number: 8010638-2014-00004
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/04/2014

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 Catalogue Number: 60620110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other