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

Catalog Number 610007

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

Patient Problems Extreme Exhaustion (1843); Dizziness (2194); Complaint, Ill-Defined (2331); Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that a pt experienced an allergic reaction after the use of irm during a dental procedure.The customer reported that this was the second time during the procedure that incorporated the use of irm, where this pt experienced a reaction.The symptoms reported were tightness of the throat, dizziness and extreme exhaustion.The pt took benadryl to combat the symptoms and is reportedly "fine".

Manufacturer Narrative

While it is unk if the device used in this case caused or contributed to the pt'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 eval, though has not been returned as of this report.Eval results will be submitted as they become available.

• Brand Name: IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w philadelphia st, ste 60; susquehanna commerce center w; york, PA 17401 ; 7178457511
• MDR Report Key: 4516752
• MDR Text Key: 5534602
• Report Number: 2515379-2015-00004
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 610007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention