Brand Name | TRANSLUX® POWER BLUE |
Type of Device | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
Manufacturer (Section D) |
HERAEUS KULZER GMBH |
gruner weg 11 |
hanau, D-63 450 |
GM D-63450 |
|
Manufacturer (Section G) |
HERAEUS KULZER GMBH |
gruner weg 11 |
|
hanau, D-63 450 |
GM
D-63450
|
|
Manufacturer Contact |
audi
bogucki
|
300 heraeus way |
south bend, IN 46614
|
5742995409
|
|
MDR Report Key | 3567359 |
MDR Text Key | 4215820 |
Report Number | 3005665377-2014-00006 |
Device Sequence Number | 1 |
Product Code |
EBZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042199 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Dental Assistant
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
12/11/2013 |
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? |
Yes
|
Device Operator |
Dentist
|
Device Catalogue Number | 66017507 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 12/11/2013 |
Device Age | 26 MO |
Initial Date Manufacturer Received |
12/11/2013 |
Initial Date FDA Received | 01/10/2014 |
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 Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|