OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E

MAUDE Adverse Event Report

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 2019-11-07 for OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E manufactured by Ogden Manufacturing Plant.

MAUDE Entry Details

• Report Number: 1713747-2019-00333
• MDR Report Key: 9292286
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-11-07
• Date of Report: 2019-11-07
• Date of Event: 2019-10-21
• Date Mfgr Received: 2019-10-23
• Device Manufacturer Date: 2018-07-30
• Date Added to Maude: 2019-11-07
• 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 F18NRE DIALYZER FINISHED ASSY
• Generic Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Product Code: FJI
• Date Received: 2019-11-07
• Catalog Number: 0500308E
• Lot Number: 18JU01019
• 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		2019-11-07