*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-27 for * manufactured by C-arms International Inc.

Event Text Entries

[463726] Pt laying prone on pain table, procedure finished - (1st) medical assistant (m. A. ) at pt's bedside. (2nd) m. A. Left room to bring recliner for pt's transfer: 1st m. A. Clearing mayo stand supplier and finishing computer info. Pt started to move rapidly and right armboard fell to floor and pt fell off the bed on right side. Pt jumped off floor and stated he was able to stand. He moved on to recliner in sitting position. Pt examined by his physician. Pt awake and did not lose consiousness. Pt coherent and conversing with medical assistants and nurse. No laceration or swelling, bruising noted. Pt denied pain to right side of body and extremities.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038348
• MDR Report Key: 697315
• Date Received: 2006-03-27
• Date of Report: 2006-03-10
• Date of Event: 2006-02-16
• Date Added to Maude: 2006-04-11
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: JFB
• Date Received: 2006-03-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 686415
• Manufacturer: C-ARMS INTERNATIONAL INC
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-03-27