*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-31 for * manufactured by *.

Event Text Entries

[15483754] During surgery a blade broke off of the swivel knife and was retrieved, though small screw continued missing. Mfr ultimately determined this product was not mfg by the co, but only repaired by it.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 83719
• MDR Report Key: 83719
• Date Received: 1995-01-31
• Date Added to Maude: 1997-04-16
• Event Key: 0
• Report Source Code: User Facility 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: *
• Generic Name: SWIVEL KNIFE
• Product Code: EMF
• Date Received: 1995-01-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 83024
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1995-01-31