GALLERY G504 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-31 for GALLERY G504 * manufactured by Vet Administration.

Event Text Entries

[530430] Va eye glasses had nose pads of plastic that smelled and irritated skin. Had optometrist change pads. The plastic did not appear cured properly.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040854
• MDR Report Key: 775365
• Date Received: 2006-10-31
• Date of Report: 2006-10-31
• Date of Event: 2006-10-01
• Date Added to Maude: 2006-11-02
• 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: PATIENT
• 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: GALLERY G504
• Generic Name: EYE GLASSES
• Product Code: HQZ
• Date Received: 2006-10-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 763145
• Manufacturer: VET ADMINISTRATION
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-10-31