MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-24 for NXSTAGE manufactured by Nxstage Medical.
[3945524]
Pt is a home hemodialysis pt who uses the nxstage machine as well as the pureflow water treatment system. Mid treatment the pt complained of feeling itchy and by the end of the treatment the pt developed a hive-like rash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032389 |
| MDR Report Key | 3434138 |
| Date Received | 2013-10-24 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-10-21 |
| Date Added to Maude | 2013-10-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NXSTAGE |
| Generic Name | DIALYSATE SYSTEM |
| Product Code | FKP |
| Date Received | 2013-10-24 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL |
| Brand Name | SA304 CONCENTRATE FOR PUREFLOW |
| Generic Name | DIALYSATE FOR HEMODIALYSIS |
| Product Code | KPO |
| Date Received | 2013-10-24 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-24 |