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

Catalog Number 60661500

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Complaint, Ill-Defined (2331); 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 results are not available as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Retain product was tested and found to be within specification.

• Brand Name: IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): DENTSPLY CAULK; milford ; DA
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st; ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4860145
• MDR Text Key: 5852005
• Report Number: 8010638-2015-00006
• 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

• Date FDA Received: 06/18/2015
• 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: 1307000087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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