Brand Name | CRYOMACS FREEZING BAG 50 |
Type of Device | CRYOMACS FREEZING BAG 50 |
Manufacturer (Section D) |
MILTENYI BIOTEC GMBH |
friedrich-ebert-strasse 68 |
bergisch gladbach, 51429 |
GM 51429 |
|
Manufacturer (Section G) |
MILTENYI BIOTEC GMBH |
friedrich-ebert-strasse 68 |
|
bergisch gladbach, 51429 |
GM
51429
|
|
Manufacturer Contact |
nancy
johansen
|
85 hamilton st |
cambridge, MA 02139
|
6172180062
|
|
MDR Report Key | 5967368 |
MDR Text Key | 55317639 |
Report Number | 3005290010-2016-00087 |
Device Sequence Number | 1 |
Product Code |
LPZ
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
09/20/2016 |
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 Expiration Date | 04/13/2018 |
Device Model Number | 200-074-400 |
Device Catalogue Number | 200-074-400 |
Device Lot Number | 6150513007 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/22/2016
|
Initial Date FDA Received | 09/21/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/09/2015 |
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 |
|
|