*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-28 for * manufactured by *.

Event Text Entries

[21959101] Pt was on the x-ray table for thoracic and lumbar spine x-rays. While the ap view of the thoracic spine was being performed, a lead filter was placed on the bottom of the x-ray tube. The filter was slightly bent on the edges and did not fit well. Upon removing the filter, it fell and struck the pt in the mid-chest. The pt stated that it struck them on the left medial lower portion of their left breast and the right medial upper portion of their right breast.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 474759
• MDR Report Key: 474759
• Date Received: 2003-07-28
• Date of Report: 2003-03-01
• Date of Event: 2003-02-01
• Date Added to Maude: 2003-08-01
• 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
• Reporter Occupation: RISK MANAGER
• 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: LEAD FILTER
• Product Code: ITY
• Date Received: 2003-07-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 463621
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-07-28