Brand Name | CRYOMACS FREEZING BAGS 750 |
Type of Device | CRYOMACS FREEZING BAGS 750 |
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 | 17197341 |
MDR Text Key | 317825175 |
Report Number | 3005290010-2023-00009 |
Device Sequence Number | 1 |
Product Code |
KSR
|
UDI-Device Identifier | 04049934000300 |
UDI-Public | 04049934000300 |
Combination Product (y/n) | N |
Reporter Country Code | US |
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,Followup |
Report Date |
06/06/2023 |
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 | 74403 |
Device Catalogue Number | 200-074-403 |
Device Lot Number | 7210800407 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/31/2023
|
Initial Date FDA Received | 06/26/2023 |
Supplement Dates Manufacturer Received | 05/31/2023
|
Supplement Dates FDA Received | 07/11/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |