MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-07-15 for OPTIFLUX F16NRE DIALYZER FINISHED ASSY OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500306E manufactured by Ogden Manufacturing Plant.
| Report Number | 1713747-2019-00205 |
| MDR Report Key | 8789408 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-07-15 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2018-11-03 |
| Date Added to Maude | 2019-07-15 |
| 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 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | DIRECTOR, SITE QUALITY 475 WEST 13TH STREET |
| Manufacturer City | OGDEN UT 84404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLUX F16NRE DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2019-07-15 |
| Returned To Mfg | 2019-08-02 |
| Model Number | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. |
| Catalog Number | 0500306E |
| Lot Number | 18PU01001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING PLANT |
| Manufacturer Address | 475 WEST 13TH STREET OGDEN UT 84404 US 84404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-15 |