MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-02 for ONEVIEW DIALYSIS MACHINE manufactured by Nxstage Medical.
[96240470]
Patient reports that on (b)(6) 2017 he went to the urologist for a prostate exam, which was found to be enlarged. His urologist ran lab work and found that his testosterone levels were extremely low. Patient states that he has been on dialysis with a device manufactured by nxstage medical. He states that this manufacturer uses the chemical dehp in their device which is a chemical that may cause negative health effects on humans and believes that this is the cause for his low testosterone levels and overall lack of energy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074346 |
| MDR Report Key | 7159794 |
| Date Received | 2018-01-02 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-09-01 |
| Date Added to Maude | 2018-01-03 |
| 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 | 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 | ONEVIEW DIALYSIS MACHINE |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2018-01-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-02 |