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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 2003-07-24 for * manufactured by *.

Event Text Entries

[327510] Problem started when an optometrist took consumer glasses to check them. The same lenses/glasses came back a couple of minutes later and had been altered. Since that time consumer has had an impossible time trying to get a normal pair made.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029112
• MDR Report Key: 474180
• Date Received: 2003-07-25
• Date of Report: 2003-07-24
• Date Added to Maude: 2003-07-30
• 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: 0
• Reporter Occupation: PATIENT
• 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: GLASSES
• Product Code: HOI
• Date Received: 2003-07-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 463026
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-07-25