Brand Name | CELLEX PHOTOPHERESIS SYSTEM |
Type of Device | CELLEX PHOTOPHERESIS SYSTEM |
Manufacturer (Section D) |
THERAKOS, INC. |
bedminster NJ 07921 |
|
Manufacturer (Section G) |
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED |
college business & tech park |
cruiserath road |
blanchardstown, dublin, D15 T X2V |
EI
D15 TX2V
|
|
Manufacturer Contact |
megan
vernak
|
1425 us route 206 |
bedminster, NJ 07921
|
|
MDR Report Key | 9333409 |
MDR Text Key | 198758235 |
Report Number | 2523595-2019-00136 |
Device Sequence Number | 1 |
Product Code |
LNR
|
UDI-Device Identifier | 20705030200003 |
UDI-Public | (01)20705030200003(10)H330(17)210501 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P860003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
11/17/2019 |
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 | 05/01/2021 |
Device Model Number | NOT APPLICABLE |
Device Catalogue Number | CLXUSA |
Device Lot Number | H330 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/19/2019
|
Initial Date FDA Received | 11/17/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/20/2019 |
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 |
Patient Age | 43 YR |
Patient Weight | 66 |