MAUDE Adverse Event Report: DENTSPLY CAULK INTEGRITY MULTI CURE; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 666640

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

In this event it was reported that a patient experienced swollen, red and painful gums after using integrity multi-care to fashion temporary crowns.The symptoms began one day after placing the temporary crowns.Three weeks later the temporary crowns were removed and the permanent crowns were placed.After the permanent crows were placed, the patient's symptoms abated.

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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: INTEGRITY MULTI CURE
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; milford DE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 3925375
• MDR Text Key: 4585210
• Report Number: 2515379-2014-00038
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101710
• 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: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 666640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TEMP BOND
• Patient Outcome(s): Other