LUXOR OPHTHALMIC MICROSCOPES E-71 8065752239

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-12 for LUXOR OPHTHALMIC MICROSCOPES E-71 8065752239 manufactured by Endure Medical, Inc..

MAUDE Entry Details

Report Number2028159-2019-01279
MDR Report Key8784879
Date Received2019-07-12
Date of Report2019-09-24
Date Mfgr Received2019-09-18
Device Manufacturer Date2013-03-19
Date Added to Maude2019-07-12
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1ENDURE MEDICAL, INC.
Manufacturer Street1455 VENTURA DR
Manufacturer CityCUMMING GA 30040
Manufacturer CountryUS
Manufacturer Postal Code30040
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report0

Device Details

Brand NameLUXOR OPHTHALMIC MICROSCOPES
Generic NameMICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
Product CodeHRM
Date Received2019-07-12
Model NumberE-71
Catalog Number8065752239
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENDURE MEDICAL, INC.
Manufacturer Address1455 VENTURA DR CUMMING GA 30040 US 30040


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-12

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