Brand Name | ARTISAN LINK PRO |
Type of Device | ARTISAN LINK PRO |
Manufacturer (Section D) |
DAKO DENMARK APS |
produktionsvej 42 |
glostrup, 2600 |
DA 2600 |
|
Manufacturer (Section G) |
DAKO NORTH AMERICA, INC. |
6392 via real |
|
carpinteria CA 93013 |
|
Manufacturer Contact |
mani
siravanta
|
6392 via real |
carpinteria, CA 93013
|
8055665462
|
|
MDR Report Key | 10584155 |
MDR Text Key | 213477357 |
Report Number | 9610099-2020-00023 |
Device Sequence Number | 1 |
Product Code |
KPA
|
UDI-Device Identifier | 05700571108451 |
UDI-Public | 05700571108451 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/24/2020 |
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 |
Health Professional
|
Device Model Number | AR310 |
Device Catalogue Number | AR31030 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/28/2020 |
Initial Date FDA Received | 09/24/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|