Brand Name | TRANSLUX WAVE |
Type of Device | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
Manufacturer (Section D) |
KULZER, GMBH |
gruner weg 11 |
hanau, gm D-634 50 |
GM D-63450 |
|
Manufacturer (Section G) |
KULZER, GMBH |
gruner weg 11 |
|
hanau, gm D-634 50 |
GM
D-63450
|
|
Manufacturer Contact |
rita
rogers
|
4315 south lafayette blvd. |
south bend 46614
|
|
MDR Report Key | 6797994 |
MDR Text Key | 83213618 |
Report Number | 3005665377-2017-00002 |
Device Sequence Number | 1 |
Product Code |
EBZ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K042199 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial,Followup |
Report Date |
08/16/2017,07/17/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Dentist
|
Device Model Number | 66055012 |
Device Catalogue Number | 66055012 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/16/2017 |
Distributor Facility Aware Date | 07/17/2017 |
Device Age | 7 MO |
Date Report to Manufacturer | 08/09/2017 |
Initial Date Manufacturer Received |
07/17/2017 |
Initial Date FDA Received | 08/16/2017 |
Supplement Dates Manufacturer Received | 07/17/2017
|
Supplement Dates FDA Received | 10/03/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/15/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|