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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-17 for * manufactured by *.

Event Text Entries

[21963452] Upon return from surgery the patient was being manually lifted from bed onto another bed with weights on halo tractor device in place at head of bed. Dr. Was giving orders to lift patient from this bed onto other bed holding patient's head/neck during movement. Another dr. Was at side of bed helping lift patient onto bed as well as nurses. Patient's halo device became dislodged or fell off of patient's head while lifting their head onto bed and requiring further sedation and new insertion of halo.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 558576
• MDR Report Key: 558576
• Date Received: 2004-11-17
• Date of Report: 2004-11-17
• Date of Event: 2004-07-04
• Report Date: 2004-11-17
• Date Reported to FDA: 2004-11-17
• Date Added to Maude: 2004-12-10
• 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: HALO FRACTION DEVICE
• Product Code: KQZ
• Date Received: 2004-11-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 548268
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-11-17