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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK JELTRATE DUSTLESS; MATERIAL, IMPRESSION
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DENTSPLY CAULK JELTRATE DUSTLESS; MATERIAL, IMPRESSION Back to Search Results
Catalog Number 689310
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
This report is for the eighth 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 eight students experienced an allergic reaction after using jeltrate alginate impression materials.No medical intervention was required.The symptoms reported include mouth sores in each student.
 
Manufacturer Narrative
The returned device failed set time, compressive strength and flow testing.Retain product was tested and found to be within specification.A dhr review was conducted with no discrepancies noted.Root cause unknown.
 
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Brand Name
JELTRATE DUSTLESS
Type of Device
MATERIAL, IMPRESSION
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
MDR Report Key8700807
MDR Text Key148057492
Report Number2515379-2019-00023
Device Sequence Number1
Product Code ELW
Combination Product (y/n)N
PMA/PMN Number
K802362
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/11/2019
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 Number689310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Initial Date Manufacturer Received 05/16/2019
Initial Date FDA Received06/14/2019
Supplement Dates Manufacturer Received06/17/2019
Supplement Dates FDA Received07/11/2019
Patient Sequence Number1
Patient Outcome(s) Other;
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