Brand Name | CELLEX PHOTOPHERESIS SYSTEM |
Type of Device | CELLEX PHOTOPHERESIS SYSTEM |
Manufacturer (Section D) |
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED |
blanchardstown, dublin, D15 T X2V |
EI D15 TX2V |
|
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
|
shelbourne building |
53 frontage rd suite 300 |
hampton, NJ 08827
|
|
MDR Report Key | 16141442 |
MDR Text Key | 308838501 |
Report Number | 3013428851-2023-00001 |
Device Sequence Number | 1 |
Product Code |
LNR
|
UDI-Device Identifier | 20705030200003 |
UDI-Public | (01)20705030200003(10)L330(17)240501 |
Combination Product (y/n) | Y |
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 |
01/11/2023 |
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 Expiration Date | 05/01/2024 |
Device Catalogue Number | CLXUSA |
Device Lot Number | L330 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/14/2022
|
Initial Date FDA Received | 01/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/31/2022 |
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 |