NEPHROS S100 70-0280

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for NEPHROS S100 70-0280 manufactured by Nephros.

Event Text Entries

[146658144] Investigation is underway. We are awaiting final investigation results and laboratory results. Upon completion, the information will be reviewed and the finding published. Anticipated completion date: june 07th 2019.
Patient Sequence No: 1, Text Type: N, H10

[146658145] The investigation is currently underway. The manufacture was informed that the customer experienced a positive legionella result.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003337893-2019-00001
• MDR Report Key: 8652580
• Date Received: 2019-05-29
• Date of Report: 2019-05-29
• Date of Event: 2019-04-29
• Date Mfgr Received: 2019-04-29
• Device Manufacturer Date: 2017-03-28
• Date Added to Maude: 2019-05-29
• 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: MRS. VASHONE THOMAS
• Manufacturer Street: 380 LACKAWANNA PLACE
• Manufacturer City: SOUTH ORANGE NJ 07079
• Manufacturer Country: US
• Manufacturer Postal: 07079
• Manufacturer Phone: 2013450829
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: NEPHROS
• Generic Name: S100
• Product Code: NHV
• Date Received: 2019-05-29
• Returned To Mfg: 2019-05-21
• Model Number: S100
• Catalog Number: 70-0280
• Lot Number: PI17/0180
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEPHROS
• Manufacturer Address: 380 LACKAWANNA PLACE SOUTH ORANGE NJ 07079 US 07079

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-29