MAGNIVISION ULTRALIGHTS NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-05-15 for MAGNIVISION ULTRALIGHTS NA manufactured by Magnivision, Inc..

Event Text Entries

[273874] Customer poked themselves in the eye with the price tag.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045828-2003-00004
• MDR Report Key: 460543
• Report Source: 00
• Date Received: 2003-05-15
• Date of Report: 2003-05-05
• Date of Event: 2003-04-24
• Date Facility Aware: 2003-05-02
• Report Date: 2003-05-05
• Date Reported to Mfgr: 2003-05-02
• Date Mfgr Received: 2003-05-02
• Date Added to Maude: 2003-05-20
• 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: 9549863284
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RC
• 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: 2003-05-15
• Model Number: ULTRALIGHTS
• Catalog Number: NA
• Lot Number: NA
• ID Number: UPC 0-24021418187
• 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: 449490
• Manufacturer: MAGNIVISION, INC.
• Manufacturer Address: 3700 COMMERCE PKWY. MIRAMAR FL 33025 US
• Baseline Brand Name: MAGNIVISION
• Baseline Generic Name: READING GLASSES
• Baseline Model No: ULTRALIGHTS
• Baseline Catalog No: NA
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2003-05-15