*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-08-20 for * manufactured by *.

MAUDE Entry Details

• Report Number: 1928508-1996-00002
• MDR Report Key: 36074
• Report Source: 05
• Date Received: 1996-08-20
• Date of Event: 1996-07-22
• Date Mfgr Received: 1996-08-05
• Date Added to Maude: 1996-08-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Product Code: FYH
• Date Received: 1996-08-20
• Device Availability: *
• Device Age: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 37495
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-08-20