Brand Name | AQUA-SEAL |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
COVIDIEN |
sragh industrial estate,rahan |
tullamore |
|
Manufacturer (Section G) |
COVIDIEN |
sragh industrial estate,rahan |
|
tullamore |
|
Manufacturer Contact |
edward
almeida
|
15 hampshire street |
mansfield, MA 02048
|
5084524151
|
|
MDR Report Key | 7138001 |
MDR Text Key | 95601763 |
Report Number | 9611018-2017-05014 |
Device Sequence Number | 1 |
Product Code |
CAC
|
UDI-Device Identifier | 20884521060965 |
UDI-Public | 20884521060965 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/28/2018 |
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 Expiration Date | 12/15/2021 |
Device Model Number | 8888571299 |
Device Catalogue Number | 8888571299 |
Device Lot Number | 16L142FHX |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/30/2017 |
Initial Date FDA Received | 12/21/2017 |
Supplement Dates Manufacturer Received | 11/30/2017
|
Supplement Dates FDA Received | 02/28/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/15/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|