RADIOLOGY FILMS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-15 for RADIOLOGY FILMS * manufactured by *.

Event Text Entries

[20348111] Concern has been raised that the font of the pt identification and info section on radiology films is small and sometimes difficult to read. There is a lot of info which is to be placed in this area and the size of this info box is uniform within the radiology film mfg industry. Smaller fonts are therefore used to enable the inclusion of all required info, which in turn makes it difficult to read the info and difficult to verify pt info.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033793
• MDR Report Key: 559503
• Date Received: 2004-11-15
• Date of Report: 2004-11-15
• Date of Event: 2004-07-12
• Date Added to Maude: 2004-12-15
• 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
• Reporter Occupation: RISK MANAGER
• 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: RADIOLOGY FILMS
• Generic Name: *
• Product Code: IWZ
• Date Received: 2004-11-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 549208
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-11-15