MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-08 for CELLEX PHOTOPHERESIS SYSTEM manufactured by Therakos.
| Report Number | 2523595-2020-00048 |
| MDR Report Key | 9804037 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-08 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-08 |
| 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 | 2020-03-08 |
| Catalog Number | CELLEX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERAKOS |
| Manufacturer Address | BEDMINSTER NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-08 |