MAGNIVISION TARA 14 *

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 TARA 14 * manufactured by Magnivision, Inc..

Event Text Entries

[15034593] Customer poked themselves in the eye with co's price label. Pt did not notice someone had broken the temple arm off the glasses and the tag fell into pt's eye.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045828-2003-00003
• MDR Report Key: 460537
• Report Source: 00
• Date Received: 2003-05-15
• Date of Report: 2003-05-05
• Date of Event: 2003-01-30
• Date Facility Aware: 2003-04-15
• Report Date: 2003-05-05
• Date Reported to Mfgr: 2003-04-15
• Date Mfgr Received: 2003-04-15
• 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: 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: 2003-05-15
• Model Number: TARA 14
• Catalog Number: *
• Lot Number: OLDER FACES LABEL
• 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: 449484
• Manufacturer: MAGNIVISION, INC.
• Manufacturer Address: 3700 COMMERCE PKWY. MIRAMAR FL 33025 US
• Baseline Brand Name: MAGNIVISION
• Baseline Generic Name: READING GLASSES
• Baseline Model No: TARA 14
• Baseline Catalog No: *
• Baseline ID: *

Patients

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