Brand Name | CRYOMACS FREEZING BAG 500 |
Type of Device | CRYOMACS FREEZING BAG 500 |
Manufacturer (Section D) |
MILTENYI BIOTEC B.V. & CO. KG |
friedrich-ebert-str. 68 |
bergisch gladbach, 51429 |
GM 51429 |
|
Manufacturer Contact |
bettina-judith
höhlich
|
friedrich-ebert-str. 68 |
bergisch gladbach, 51429
|
GM
51429
|
|
MDR Report Key | 13584437 |
MDR Text Key | 290790126 |
Report Number | 3005290010-2022-00001 |
Device Sequence Number | 1 |
Product Code |
KSR
|
UDI-Device Identifier | 04049934000294 |
UDI-Public | 4049934000294 |
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | BK090020 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/18/2022 |
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 Catalogue Number | 200-074-402 |
Device Lot Number | 720100638 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/26/2022
|
Initial Date FDA Received | 02/23/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |