MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2014-05-20 for GRANUFLO manufactured by Fresenius Medical Care North America.
[18728353]
The plaintiff's attorney alleged that the decedent experienced cardiovascular events on or about 2000 and (b)(6) 2008 and subsequently expired on (b)(6) 2010, after the use of the product.
Patient Sequence No: 1, Text Type: D, B5
[18861047]
This is one event (cardiovascular) of three events for the same pt involving two separate products; associated mdrs #1225714-2014-03112, 03113, 03115, 03116, and 03117.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225714-2014-03114 |
| MDR Report Key | 3848415 |
| Report Source | 00,04 |
| Date Received | 2014-05-20 |
| Date of Report | 2014-04-23 |
| Date of Event | 2008-12-01 |
| Date Mfgr Received | 2014-04-23 |
| Date Added to Maude | 2014-06-05 |
| 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 | GRANUFLO |
| Product Code | KPO |
| Date Received | 2014-05-20 |
| 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 | 2014-05-20 |