MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-21 for CELLEX CLXUSA manufactured by Therakos, Inc..
Report Number | 9353625 |
MDR Report Key | 9353625 |
Date Received | 2019-11-21 |
Date of Report | 2019-11-12 |
Date of Event | 2019-11-08 |
Report Date | 2019-11-12 |
Date Reported to FDA | 2019-11-12 |
Date Reported to Mfgr | 2019-11-21 |
Date Added to Maude | 2019-11-21 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CELLEX |
Generic Name | SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL |
Product Code | LNR |
Date Received | 2019-11-21 |
Model Number | CLXUSA |
Catalog Number | CLXUSA |
Lot Number | H338 |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | THERAKOS, INC. |
Manufacturer Address | 1425 US ROUTE 206 BEDMINSTER NJ 07921 US 07921 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-21 |