MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-16 for "REDY" manufactured by .
[844469]
Twelve deaths since 2008 at hospital, on dialysis machine, or after dialysis. Diagnosis or reason for use: dialysis. Machine cleaned after each treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5006289 |
| MDR Report Key | 1031488 |
| Date Received | 2008-04-17 |
| Date Added to Maude | 2008-04-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "REDY" |
| Generic Name | DIALYSIS MACHINE |
| Product Code | FKT |
| Date Received | 2008-04-16 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 998845 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-04-17 |