MAGNIVISION * NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2001-08-23 for MAGNIVISION * NA manufactured by Magnivision, Inc..

Event Text Entries

[245486] Consumer poked self in the eye with the "hang tag" label.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045828-2001-00004
• MDR Report Key: 349034
• Report Source: 00,04
• Date Received: 2001-08-23
• Date of Report: 2001-08-21
• Date of Event: 1997-01-01
• Date Facility Aware: 2001-08-13
• Report Date: 2001-08-21
• Date Mfgr Received: 2001-08-13
• Date Added to Maude: 2001-08-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 3700 COMMERCE PARKWAY
• Manufacturer City: MIRAMAR FL 33025
• Manufacturer Country: US
• Manufacturer Postal: 33025
• Manufacturer Phone: 9549869000
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAGNIVISION
• Generic Name: READING GLASSES
• Product Code: HOI
• Date Received: 2001-08-23
• Model Number: *
• Catalog Number: NA
• Lot Number: NA
• ID Number: *
• Operator: OTHER
• Device Availability: N
• Device Age: NO INFO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 338351
• Manufacturer: MAGNIVISION, INC.
• Manufacturer Address: 3700 COMMERCE PARKWAY MIRAMAR FL 33025 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-08-23