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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM; CROWN AND BRIDGE, TEMPORARY, RESIN
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DENTSPLY CAULK INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM; CROWN AND BRIDGE, TEMPORARY, RESIN Back to Search Results
Catalog Number 666220
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414)
Event Date 09/05/2019
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.This report is for the third patient.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
It was reported that four patients experienced a reaction to integrity temporary c&b material.This patient broke out in blisters.Magic mouth wash was given to combat the patient's symptoms.The reaction subsided in a few days.
 
Manufacturer Narrative
Retained product was teste and found to be within specification.
 
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Brand Name
INTEGRITY TEMPORARY CROWN & BRIDGE MATERIAL-CARTRIDGE SYSTEM
Type of Device
CROWN AND BRIDGE, TEMPORARY, RESIN
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
MDR Report Key9204596
MDR Text Key175062768
Report Number2515379-2019-00028
Device Sequence Number1
Product Code EBG
Combination Product (y/n)N
PMA/PMN Number
K013674
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number666220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age42 YR
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