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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK CALIBRA; CEMENT, DENTAL
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DENTSPLY CAULK CALIBRA; CEMENT, DENTAL Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
It is presumed that the patient was not using the product correctly.Regardless, an allergic reaction cannot be ruled out.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
A patient reported that their doctor gave them calibra cement to recement their crown until the patient could get into the office.The patient has a sore on their gums and a burning sensation.
 
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Brand Name
CALIBRA
Type of Device
CEMENT, DENTAL
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
MDR Report Key10881533
MDR Text Key217645767
Report Number2515379-2020-00010
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 11/20/2020
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/21/2020
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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