Brand Name | DUO FLUID CART |
Type of Device | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
Manufacturer (Section D) |
DORNOCH |
200 northwest parkway |
riverside MO 64150 |
|
Manufacturer (Section G) |
DORNOCH |
200 northwest parkway |
|
riverside MO 64150 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell drive |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 7660413 |
MDR Text Key | 113397086 |
Report Number | 0001954182-2018-00041 |
Device Sequence Number | 1 |
Product Code |
JCX
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | P K162421 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,USER F |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
07/19/2018 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 07/03/2018 |
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 | 00514010100 |
Device LOT Number | 0027215 |
OTHER Device ID Number | (01)00889024465992 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 07/16/2018 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 07/18/2018 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 02/14/2018 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
|
|