YELLOFIN ELITE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-15 for YELLOFIN ELITE * manufactured by Allen Medical Systems, Inc..

Event Text Entries

[16082546] The patient's legs were being positioned and as the surgical technician adjusted the yellofin stirrup, it broke. There was no patient injury. The patient weighed 110 pounds and her leg was caught before it hit the operating floor. This has occurred on 3 separate occasions.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3590695
• MDR Report Key: 3590695
• Date Received: 2014-01-15
• Date of Report: 2014-01-15
• Date of Event: 2014-01-13
• Report Date: 2014-01-15
• Date Added to Maude: 2014-01-24
• 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: 3
• 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 Sequence Number: 1

• Brand Name: YELLOFIN ELITE
• Generic Name: STIRRUPS
• Product Code: EYD
• Date Received: 2014-01-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALLEN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1 POST OFFICE SQUARE ACTON MA 01720 US 01720

Device Sequence Number: 2

• Brand Name: YELLOFIN ELITE
• Generic Name: STIRRUPS
• Product Code: EYD
• Date Received: 2014-01-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ALLEN MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1 POST OFFICE SQUARE ACTON MA 01720 US 01720

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-01-15