FDA Adverse Event
Injury
Summary report: N
PREMISE
MDR report key: 2233582
·
Received September 2, 2011
Report
- Report Number
- 2024312-2011-00226
- Event Type
- Injury
- Date Received
- September 2, 2011
- Report Date
- August 1, 2011
- Manufacturer
- KERR CORPORATION
- Product Code
- EBF
- PMA / PMN Number
- K060472
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
A CUSTOMER ALLEGED THAT PREMISE MATERIAL IS SETTING AT AN ORANGE COLOR. THE PRODUCT WAS RETURNED AND EVALUATED. ALL RESULTS WERE WITHIN SPECIFICATIONS AND NO CONTAMINATION OR OTHER STRANGE MATTERS WERE DETECTED IN THE MATERIAL.
Additional Manufacturer Narrative · 1
A CUSTOMER ALLEGED THAT PREMISE MATERIAL IS SETTING AT AN ORANGE COLOR. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION REGARDING REQUIRED TREATMENT OR THE PATIENT'S CONDITION HAS BEEN PROVIDED. RETAIN SAMPLES WILL BE EVALUATED.
Description of Event or Problem · 1
ON (B)(6), 2011 A CUSTOMER ALLEGED THAT THE PREMISE PRODUCT WAS SETTING AT AN ORANGE COLOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMISE | MATERIAL, TOOTH SHADE RESIN | EBF | KERR CORPORATION | 3491102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |