MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-14 for CATSMART N/A 9005081 manufactured by Fresenius Hemocare Gmbh.
| Report Number | 3004634229-2019-00002 |
| MDR Report Key | 8895376 |
| Report Source | USER FACILITY |
| Date Received | 2019-08-14 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-07-19 |
| Date Facility Aware | 2019-07-19 |
| Report Date | 2019-07-19 |
| Date Reported to Mfgr | 2019-07-19 |
| Date Mfgr Received | 2019-07-19 |
| Date Added to Maude | 2019-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Manufacturer Contact | MS. VICKI MCKEE |
| Manufacturer Street | 3 CORPORATE DRIVE |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8475500157 |
| Manufacturer G1 | FRESENIUS HEMOCARE GMBH |
| Manufacturer Street | GRUENER WEG 10 |
| Manufacturer City | FRIEDBERG HESSEN, D-61169 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61169 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATSMART |
| Generic Name | CATSMART |
| Product Code | CAC |
| Date Received | 2019-08-14 |
| Model Number | N/A |
| Catalog Number | 9005081 |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS HEMOCARE GMBH |
| Manufacturer Address | GRUENER WEG 10 FRIEDBERG HESSEN, D-61169 GM D-61169 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-08-14 |