MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-28 for CONTOUR manufactured by Kerr Corporation.
[3133695]
A doctor reported that immediately after having placed twelve (12) contour alloy restorations for a patient, the patient alleged experiencing sensitivity. The patient also alleged at a later date that all twelve (12) restorations had tarnished within two (2) weeks of placement.
Patient Sequence No: 1, Text Type: D, B5
[10550326]
Patient information with regard to age and weight could not be recalled. The doctor reported that after the procedure was finished, the patient had requested vicodin to alleviate sensitivity. The doctor refused to give the patient the prescription. The patient then allegedly left his office and immediately went to the er to seek further treatment for the sensitivity. The er doctor purportedly prescribed the patient vicodin for treatment. The doctor stated that afterwards, the patient visited at least three (3) other dentists within a 48 hour period of time and attained prescriptions for vicodin from each one. The last dentist the patient had visited alleged that the all of the contour restorations were tarnished and causing sensitivity because they had not been properly condensed. This dentist replaced all twelve (12) restorations approximately two (2) weeks after the initial placement of the alloy. No further information with regard to the patient could be provided by the doctor as he had not seen her since that initial visit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2013-00001 |
| MDR Report Key | 2983583 |
| Report Source | 05 |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-01 |
| Date Mfgr Received | 2013-02-01 |
| Device Manufacturer Date | 2010-09-09 |
| Date Added to Maude | 2013-03-01 |
| 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. WENDY GARMAN |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| 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 | 2013-02-28 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-02-28 |