MAUDE Adverse Event Report: DENTSPLY CAULK IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL; DENTAL CEMENT

Catalog Number 60661500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 05/11/2015

Event Type  Injury  

Event Description

In this event it was reported that a patient experienced an allergic reaction after the use of irm cement.The patient developed a cough, which worsened and then had difficulty breathing.The patient saw her doctor who prescribed an antihistaminic drug.The patient has since recovered.

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.

Manufacturer Narrative

The device was evaluated and found to be within spec.

• Brand Name: IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st; ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4860127
• MDR Text Key: 5852006
• Report Number: 8010638-2015-00007
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PREAMENDM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

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 Catalogue Number: 60661500
• Device Lot Number: 1502000532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• 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