MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2014-09-22 for NATURALYTE manufactured by Fresenius Medical Care North America.
[19538497]
This is one event (cerebrovascular) for the same patient involving two separate products.
Patient Sequence No: 1, Text Type: N, H10
[19561619]
The plaintiff's attorney alleged that the patient experienced a cerebrovascular event on or about (b)(6) 2012 after the use of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225714-2014-12224 |
| MDR Report Key | 4128196 |
| Report Source | 00,04 |
| Date Received | 2014-09-22 |
| Date of Report | 2014-09-12 |
| Date of Event | 2014-06-25 |
| Date Mfgr Received | 2014-09-12 |
| Date Added to Maude | 2014-10-01 |
| 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 024511457 |
| Manufacturer Country | US |
| Manufacturer Postal | 024511457 |
| 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 | 2014-09-22 |
| 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. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2014-09-22 |