Brand Name | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR |
Type of Device | COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET |
Manufacturer (Section D) |
FRESENIUS HEMOCARE NETHERLANDS B.V. |
runde zz 41 |
emmer-compascuum, NL-78 81 H |
NL NL-7881 HM |
|
Manufacturer (Section G) |
FRESENIUS HEMOCARE NETHERLANDS B.V. |
runde zz 41 |
|
emmer-compascuum, NL-78 81 H |
NL
NL-7881 HM
|
|
Manufacturer Contact |
rebecca
mccandless
|
3 corporate drive |
lake zurich, IL 60047
|
8475502300
|
|
MDR Report Key | 10673470 |
MDR Text Key | 211262884 |
Report Number | 3002807758-2020-00003 |
Device Sequence Number | 1 |
Product Code |
LKN
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K060734 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/27/2020 |
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 |
Other
|
Device Model Number | N/A |
Device Catalogue Number | 9400408 |
Device Lot Number | KAT 203 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/27/2020
|
Initial Date FDA Received | 10/13/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/20/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |