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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Sensitivity of Teeth (2427)
Event Type  Injury  
Event Description
On (b)(6) 2014, a doctor's office had alleged that six (6) patients had experienced pain and sensitivity after placement of restorations using the herculite ultra product.This is the sixth of six (6) reports.
 
Manufacturer Narrative
Specific patient information such as age and weight was not provided.Although the doctor identified six (6) different lots associated with the sensitivity issues, the doctor could not verify which lot was used on any of the patients.The lots involved in the alleged incident include lot numbers 4887139 (catalog #34349), 4880077 (catalog #34776), 4444999 (catalog #34350), 4734549 (catalog #34448), and two (2) unknown lot numbers (catalog #34347 and #34348).The doctor removed and replaced the patient's restoration using a different product, without further incident.To date, the patient is doing fine.The product involved in the alleged incident was not returned.A visual and physical evaluation was performed on retained samples from the same lots for lot numbers 4887139, 4880077, and 4734549, yielding results within specifications.The lot number 4444999 was expired product; therefore, no further evaluation can be conducted.
 
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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 Key4306025
MDR Text Key5272917
Report Number2024312-2014-00676
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
Report Date 11/10/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2014
Initial Date FDA Received12/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
OPTIBOND SOLO PLUS
Patient Outcome(s) Other; Required Intervention;
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