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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK PRIME & BOND NT LIGHT CURED TOTAL-ETCH DENTAL ADHESIVE SYSTEM; AGENT, TOOTH BONDING, RESIN

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DENTSPLY CAULK PRIME & BOND NT LIGHT CURED TOTAL-ETCH DENTAL ADHESIVE SYSTEM; AGENT, TOOTH BONDING, RESIN Back to Search Results
Catalog Number 634350
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
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.
 
Event Description
It was reported that a patient experienced an allergic reaction after undergoing a routine dental procedure with prime & bond nt as one of the materials.The symptoms subsided and there was no medical intervention provided at this time.The patient is seeing an allergist for testing, but further details are not available as of this mdr evaluation.
 
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Brand Name
PRIME & BOND NT LIGHT CURED TOTAL-ETCH DENTAL ADHESIVE SYSTEM
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
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key9203237
MDR Text Key163117456
Report Number2515379-2019-00025
Device Sequence Number1
Product Code KLE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 10/04/2019
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 Number634350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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