Brand Name | EVAC STATION |
Type of Device | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
Manufacturer (Section D) |
DORNOCH |
200 northwest parkway |
riverside MO 64150 |
|
MDR Report Key | 7300108 |
MDR Text Key | 101172018 |
Report Number | 0001954182-2018-00015 |
Device Sequence Number | 1 |
Product Code |
JCX
|
Combination Product (y/n) | N |
PMA/PMN Number | PSEE H10 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
03/09/2018 |
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 | N/A |
Device Catalogue Number | ULEV100 |
Device Lot Number | N/A |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/13/2018 |
Initial Date FDA Received | 02/27/2018 |
Supplement Dates Manufacturer Received | 03/08/2018
|
Supplement Dates FDA Received | 03/09/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|