MAUDE Adverse Event Report: DENTSPLY CAULK IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIAL; CEMENT, DENTAL

Catalog Number 610200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 10/08/2016

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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a patient experienced an allergic reaction after undergoing a restorative procedure with irm as one of the materials.The patient developed moderate rash that eventually subsided.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIAL
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178457551
• MDR Report Key: 6648889
• MDR Text Key: 77822647
• Report Number: 2515379-2017-00009
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 610200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other