REDI-READERS RR 5212 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-14 for REDI-READERS RR 5212 * manufactured by Magnivision, Inc..

Event Text Entries

[397273] Customer claimed to have a burning sensation and rash near nose pads when wearing a new pair of company's glasses. They normally wear company's glasses with no problems including this same style.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1045828-2004-00001
MDR Report Key597763
Date Received2004-06-14
Date of Report2004-05-26
Date of Event2004-05-13
Date Facility Aware2004-05-25
Report Date2004-05-26
Date Added to Maude2005-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street3700 COMMERCE
Manufacturer CityMIRAMAR FL 33025
Manufacturer CountryUS
Manufacturer Postal33025
Manufacturer Phone*
Manufacturer G1MAGNIVISION
Manufacturer Street3700 COMMERCE
Manufacturer CityMIRAMAR FL 33025
Manufacturer CountryUS
Manufacturer Postal Code33025
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREDI-READERS
Generic Name5200 SERIES
Product CodeHOI
Date Received2004-06-14
Model NumberRR 5212
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device Availability*
Device AgeNO INFO
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key587596
ManufacturerMAGNIVISION, INC.
Manufacturer Address3700 COMMERCE PKWY. MIRAMAR FL 33025 US
Baseline Brand NameREDI-READERS
Baseline Generic Name5200 SERIES
Baseline Model NoRR 5212
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-06-14

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