Brand Name | MECTA SPECTRUM 5000Q |
Type of Device | ECTDEVICE |
Manufacturer (Section D) |
MECTA CORPORATION |
19799 sw 95th ave. suite b |
tualatin OR 97062 |
|
Manufacturer (Section G) |
MECTA CORPORATION |
19799 sw 95th avenue suite b |
|
tualatin OR 97062 |
|
Manufacturer Contact |
robin
nicol
|
19799 sw 95th avenue suite b |
tualatin, OR 97062
|
5036126780
|
|
MDR Report Key | 7294050 |
MDR Text Key | 100888652 |
Report Number | 3020533-2018-00007 |
Device Sequence Number | 1 |
Product Code |
GXC
|
Combination Product (y/n) | N |
PMA/PMN Number | K965070 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
literature,other |
Type of Report
| Initial |
Report Date |
01/11/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/23/2018 |
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | SPECTRUM 5000 Q |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 05/20/2016 |
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 |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|