MAUDE Adverse Event Report: DENTSPLY CAULK PRIME & BOND ELECT UNIVERSAL DENTAL ADHESIVE-LIGHT CURE; AGENT, TOOTH BONDING, RESIN

Catalog Number 634601

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injury (2348); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device used in this case caused or contributed to the patient's symptoms.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.

Event Description

In this event it was reported that a patient experienced an adverse reaction after undergoing treatment with prime & bond elect adhesive as one of the bonding agents.The patient returned a few days after treatment with blisters in their mouth.The doctor prescribed medral dose pack for the patient.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: PRIME & BOND ELECT UNIVERSAL DENTAL ADHESIVE-LIGHT CURE
• Type of Device: AGENT, TOOTH BONDING, RESIN
• 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 ; 7178494229
• MDR Report Key: 5290090
• MDR Text Key: 33304672
• Report Number: 2515379-2015-00077
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

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: 634601
• Device Lot Number: 140613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention