Brand Name | ARTISAN ACID-FAST BACILLUS (AFB) STAIN KIT |
Type of Device | ARTISAN ACID-FAST BACILLUS (AFB) STAIN KIT |
Manufacturer (Section D) |
DAKO NORTH AMERICA, INC |
6392 via real |
carpinteria, ca, ca |
|
Manufacturer (Section G) |
DAKO DENMARK APS |
produktionsvej 42 |
|
glostrup, 2600 |
DA
2600
|
|
Manufacturer Contact |
thiago
lima
|
produktionsvej 42 |
glostrup, 2600
|
DA
2600
|
|
MDR Report Key | 10453306 |
MDR Text Key | 206862259 |
Report Number | 2022180-2020-00301 |
Device Sequence Number | 1 |
Product Code |
ICL
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
08/26/2020 |
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 | AR162 |
Device Catalogue Number | AR16211-2 |
Device Lot Number | 11161695 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/27/2020 |
Initial Date FDA Received | 08/26/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |