OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500316E

MAUDE Adverse Event Report

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 2020-03-23 for OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500316E manufactured by Ogden Manufacturing Plant.

MAUDE Entry Details

• Report Number: 1713747-2020-00076
• MDR Report Key: 9866583
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-23
• Date of Report: 2020-03-23
• Date of Event: 2020-03-06
• Date Mfgr Received: 2020-03-06
• Date Added to Maude: 2020-03-23
• 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

Device Details

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• Generic Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Product Code: KDI
• Date Received: 2020-03-23
• Model Number: 0500316E
• Catalog Number: 0500316E
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: MO
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OGDEN MANUFACTURING PLANT
• Manufacturer Address: DIRECTOR, SITE QUALITY 475 WEST 13TH STREET OGDEN UT 84404 US 84404

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-23