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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 2005-01-04 for * manufactured by Unk.

Event Text Entries

[314617] Transilluminator used to obtain blood cultures by making the veins more visible. Transilluminator used on pt's hands, elbow and feet. Pt has 2 blisters on left hand and 1 blister on right elbow. Blisters suspected to be from heat of transilluminator. Transilluminator sent to biomed. They found the locking ring to be missing. Replaced locking ring.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 565102
• MDR Report Key: 565102
• Date Received: 2005-01-04
• Date of Report: 2005-01-04
• Date of Event: 2004-09-20
• Report Date: 2005-01-04
• Date Reported to FDA: 2005-01-04
• Date Added to Maude: 2005-01-13
• 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: TRANSILLUMINATOR
• Product Code: HBI
• Date Received: 2005-01-04
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 554874
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-01-04