XENON UNIVERSAL LIGHT SOURCE 300 WATT LS7700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-12 for XENON UNIVERSAL LIGHT SOURCE 300 WATT LS7700 manufactured by Consolidated Medical Equipment.

MAUDE Entry Details

Report Number3007305485-2019-00227
MDR Report Key8786227
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-12
Date of Report2019-07-26
Date of Event2019-06-17
Date Mfgr Received2019-07-22
Device Manufacturer Date2012-02-08
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 ContactMELANIE LANNON
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995209
Manufacturer G1CONSOLIDATED MEDICAL EQUIPMENT
Manufacturer StreetALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA
Manufacturer City31136
Manufacturer CountryMX
Manufacturer Postal Code31136
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXENON UNIVERSAL LIGHT SOURCE 300 WATT
Generic NameLIGHT SOURCE
Product CodeGCT
Date Received2019-07-12
Returned To Mfg2019-07-08
Catalog NumberLS7700
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCONSOLIDATED MEDICAL EQUIPMENT
Manufacturer AddressALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA 31136 MX 31136


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-12

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