CONTOUR 29976

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-22 for CONTOUR 29976 manufactured by Kerr Corporation.

Event Text Entries

[12394900] A visual and physical evaluation was performed on the returned product, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10


[16180238] A doctor alleged that the contour amalgam had fractured at the cusps when checking the occlusion for three (3) patients. This is the first of three (3) reports.
Patient Sequence No: 1, Text Type: D, B5


[16316883] Specific information with regard to the patient's gender, age, and weight was not provided. The doctor reported that he drilled out and replaced the patient's restoration during the same office visit. To date, the patient is doing fine. The product involved in the alleged incident was not returned; therefore, a visual and physical evaluation was performed on a retained sample, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1815757-2014-00007
MDR Report Key4031356
Report Source05
Date Received2014-08-22
Date of Report2014-08-07
Date Mfgr Received2014-08-07
Date Added to Maude2014-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. KERRI CASINO
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167634
Manufacturer G1KERR CORPORATION
Manufacturer Street28200 WICK ROAD
Manufacturer CityROMULUS MI 48174
Manufacturer CountryUS
Manufacturer Postal Code48174
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTOUR
Generic NameDENTAL AMALGAM, MERCURY, AND AMALGAM ALLOY
Product CodeEJJ
Date Received2014-08-22
Catalog Number29976
Lot Number4-1170
Device Expiration Date2017-06-30
OperatorDENTIST
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKERR CORPORATION
Manufacturer Address28200 WICK ROAD ROMULUS MI 48174 US 48174


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-08-22

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