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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERR CORPORATION POINT 4 COMPOSITE; TOOTH SHADE RESIN MATERIAL
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KERR CORPORATION POINT 4 COMPOSITE; TOOTH SHADE RESIN MATERIAL Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
A doctor alleged that multiple patients had experienced chipping of their restorations.
 
Manufacturer Narrative
Patient information with regard to gender, age and weight was not provided.The doctor could not recall specific number of patients or incident details.The doctor patched up the restorations for each of the patient.To date, all of the patients are doing fine.The product was not returned and no lot number was provided; therefore, no evaluation can be conducted.
 
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Brand Name
POINT 4 COMPOSITE
Type of Device
TOOTH SHADE RESIN MATERIAL
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 Key3629081
MDR Text Key3983973
Report Number2024312-2014-00107
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K013510
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 02/06/2014
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 02/06/2014
Initial Date FDA Received02/14/2014
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
Patient Outcome(s) Other; Required Intervention;
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