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 Number1045828-2001-00004
MDR Report Key349034
Report Source00,04
Date Received2001-08-23
Date of Report2001-08-21
Date of Event1997-01-01
Date Facility Aware2001-08-13
Report Date2001-08-21
Date Mfgr Received2001-08-13
Date Added to Maude2001-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street3700 COMMERCE PARKWAY
Manufacturer CityMIRAMAR FL 33025
Manufacturer CountryUS
Manufacturer Postal33025
Manufacturer Phone9549869000
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAGNIVISION
Generic NameREADING GLASSES
Product CodeHOI
Date Received2001-08-23
Model Number*
Catalog NumberNA
Lot NumberNA
ID Number*
OperatorOTHER
Device AvailabilityN
Device AgeNO INFO
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key338351
ManufacturerMAGNIVISION, INC.
Manufacturer Address3700 COMMERCE PARKWAY MIRAMAR FL 33025 US


Patients

Patient NumberTreatmentOutcomeDate
10 2001-08-23

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