MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2015-04-21 for NATURALYTE manufactured by Fresenius Medical Care North America.
[15229339]
The plaintiff's attorney alleged that the patient experienced a sudden cardiac event and expired three days later. These claims were allegedly caused by the exposure to the product administered during dialysis treatment.
Patient Sequence No: 1, Text Type: D, B5
[15256973]
This is one event for the same patient involving two separate products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225714-2015-02076 |
| MDR Report Key | 4722118 |
| Report Source | 00,04 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-07 |
| Date of Event | 2013-02-01 |
| Date Mfgr Received | 2015-04-07 |
| Date Added to Maude | 2015-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CORIE VAZQUEZ |
| Manufacturer Street | 920 WINTER STREET |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURALYTE |
| Product Code | KOP |
| Date Received | 2015-04-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening | 2015-04-21 |