MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-13 for COLLECTIVE CONCENTRATE- GRANUFLO UNKNOWN- CONCENTRATE- GRANUFLO manufactured by Oregon Manufacturing Plant.
| Report Number | 3005162618-2019-00035 |
| MDR Report Key | 9315775 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-13 |
| Date of Report | 2019-11-13 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | OREGON MANUFACTURING PLANT |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 750 N LALLENDORF ROAD |
| Manufacturer City | OREGON OH 43616 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLECTIVE CONCENTRATE- GRANUFLO |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2019-11-13 |
| Catalog Number | UNKNOWN- CONCENTRATE- GRANUFLO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OREGON MANUFACTURING PLANT |
| Manufacturer Address | DIRECTOR, QUALITY SYSTEMS 750 N LALLENDORF ROAD OREGON OH 43616 US 43616 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-11-13 |