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.
[4849092]
A doctor alleged that the contour amalgam had fractured at the cusps when checking the occlusion for three (3) patients. This is the third of three (3) reports.
Patient Sequence No: 1, Text Type: D, B5
[12009370]
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
[12339378]
A visual and physical evaluation was performed on the returned product, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2014-00009 |
| MDR Report Key | 4031376 |
| Report Source | 05 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-08-07 |
| Date Mfgr Received | 2014-08-07 |
| Date Added to Maude | 2014-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 28200 WICK ROAD |
| Manufacturer City | ROMULUS MI 48174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR |
| Generic Name | DENTAL AMALGAM, MERCURY, AND AMALGAM ALLOY |
| Product Code | EJJ |
| Date Received | 2014-08-22 |
| Catalog Number | 29976 |
| Lot Number | 4-1170 |
| Device Expiration Date | 2017-06-30 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 28200 WICK ROAD ROMULUS MI 48174 US 48174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-08-22 |