ANNE KLEIN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-21 for ANNE KLEIN * manufactured by *.

Event Text Entries

[375409] Eyeglasses that pt had bought one year earlier fell apart on and pt was unable to see. Pt took them back to the place of purchase and pt was looked upon as if they meant to break them. Pt paid for them with a credit card and credit card company stood behind them, but the place where pt purchased them didn't. Pt has been wearing eyeglasses since they were 3 years old. Pt knows how to take care of them since they need them to see.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034111
• MDR Report Key: 564017
• Date Received: 2004-11-21
• Date of Report: 2004-11-21
• Date Added to Maude: 2005-01-10
• 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: 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: ANNE KLEIN
• Generic Name: EYEGLASSES
• Product Code: HQZ
• Date Received: 2004-11-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 553751
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2004-11-21