MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-31 for CELLEX PHOTOPHERESIS SYSTEM NOT APPLICABLE CLXECP manufactured by Therakos Inc..
Report Number | 2523595-2020-00016 |
MDR Report Key | 9655035 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-01-31 |
Date of Report | 2020-01-31 |
Date of Event | 2020-01-03 |
Date Mfgr Received | 2020-01-03 |
Device Manufacturer Date | 2019-08-05 |
Date Added to Maude | 2020-01-31 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MEGAN VERNAK |
Manufacturer Street | 1425 US ROUTE 206 |
Manufacturer City | BEDMINSTER NJ 07921 |
Manufacturer Country | US |
Manufacturer Postal | 07921 |
Manufacturer G1 | MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED |
Manufacturer Street | COLLEGE BUSINESS & TECH PARK CRUISERATH ROAD |
Manufacturer City | BLANCHARDSTOWN, DUBLIN, D15 TX2V |
Manufacturer Country | EI |
Manufacturer Postal Code | D15 TX2V |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CELLEX PHOTOPHERESIS SYSTEM |
Generic Name | CELLEX PHOTOPHERESIS SYSTEM |
Product Code | LNR |
Date Received | 2020-01-31 |
Model Number | NOT APPLICABLE |
Catalog Number | CLXECP |
Lot Number | H143 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | THERAKOS INC. |
Manufacturer Address | BEDMINSTER NJ 07921 US 07921 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-01-31 |