Brand Name | AURORA2 SERIES |
Type of Device | LIGHT, SURGICAL, FLOOR STANDING |
Manufacturer (Section D) |
DKK DAI-ICHI SHOMEI CO., LTD. |
32-26, sakashita 1-chome |
itabashi-ku, 174-0 043 |
JA 174-0043 |
|
Manufacturer (Section G) |
DKK DAI-ICHI SHOMEI CO., LTD. |
32-26, sakashita 1-chome |
|
itabashi-ku, 174-0 043 |
JA
174-0043
|
|
Manufacturer Contact |
kenneth
block
|
800 e. campbell road |
suite 202 |
richardson, TX 75081
|
9724809554
|
|
MDR Report Key | 9498073 |
MDR Text Key | 190690510 |
Report Number | 3006437518-2019-00003 |
Device Sequence Number | 1 |
Product Code |
FSS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial |
Report Date |
12/19/2019 |
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 |
Health Professional
|
Device Model Number | AUR55 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/23/2015 |
Initial Date FDA Received | 12/19/2019 |
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) |
Other;
|
|
|