MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-19 for GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL 0FD2251-3B manufactured by Oregon Manufacturing Plant.
| Report Number | 3005162618-2019-00030 |
| MDR Report Key | 8808078 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-19 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-06-19 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2019-04-29 |
| Date Added to Maude | 2019-07-19 |
| 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 |
| 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 | GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2019-07-19 |
| Catalog Number | 0FD2251-3B |
| Lot Number | 19DXGF022 |
| 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 | 750 N LALLENDORF ROAD OREGON OH 43616 US 43616 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2008 | 1. Required No Informationntervention | 2019-07-19 |