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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR CORPORATION HERCULITE ULTRA; MATERIAL, TOOTH SHADE, RESIN

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KERR CORPORATION HERCULITE ULTRA; MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Catalog Number 34348
Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
A doctor alleged that the herculite ultra composite was radiolucent on x-rays for four (4) patients.This is the third of four (4) reports.
 
Manufacturer Narrative
Specific patient information with regard to gender, age, and weight was not provided.It was reported that the doctor completed the restoration and took an x-ray for insurance purposes.On the x-ray, the doctor discovered that a radiolucent composite restoration.The doctor drilled out and replaced the restoration for the patient.To date, the patient is doing fine.An evaluation is anticipated but has not yet begun.
 
Manufacturer Narrative
The product involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample from the same lot, yielding results within specification.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.
 
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Brand Name
HERCULITE ULTRA
Type of Device
MATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
KERR CORPORATION
1717 west collins avenue
orange CA 92867
Manufacturer (Section G)
KERR CORPORATION
1717 west collins avenue
orange CA 92867
Manufacturer Contact
kerri casino
1717 west collins avenue
orange, CA 92867
7145167634
MDR Report Key4139764
MDR Text Key4911701
Report Number2024312-2014-00627
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 09/03/2014
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 Dentist
Device Catalogue Number34348
Device Lot Number4605473
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/03/2014
Initial Date FDA Received10/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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