UNKNOWN DISTRIBUTED DIALYZER * 0000018

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-24 for UNKNOWN DISTRIBUTED DIALYZER * 0000018 manufactured by *.

Event Text Entries

[65364] Dr facility alleges the venous transducer blew off machine. Ebl 150cc. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2243621-1996-05868
• MDR Report Key: 103977
• Date Received: 1996-04-24
• Date of Report: 1996-02-08
• Date of Event: 1992-02-10
• Date Facility Aware: 1992-02-10
• Report Date: 1996-02-08
• Date Added to Maude: 1997-07-10
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNKNOWN DISTRIBUTED DIALYZER
• Generic Name: *
• Product Code: FIB
• Date Received: 1996-04-24
• Model Number: *
• Catalog Number: 0000018
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 102300
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-04-24