BIS 186-0106

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 2019-09-04 for BIS 186-0106 manufactured by Mmj Sa De Cv (usd).

MAUDE Entry Details

Report Number2936999-2019-00681
MDR Report Key8961034
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-04
Date of Report2019-09-04
Date of Event2018-06-20
Date Mfgr Received2019-08-12
Device Manufacturer Date2017-09-24
Date Added to Maude2019-09-04
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 ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1MMJ SA DE CV (USD)
Manufacturer StreetAVE HENEQUEN NO 1181 DESARROLL
Manufacturer CityCIUDAD JUAREZ 32590
Manufacturer CountryMX
Manufacturer Postal Code32590
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIS
Generic NameELECTRODE, CUTANEOUS
Product CodeGXY
Date Received2019-09-04
Model Number186-0106
Catalog Number186-0106
Lot Number0924171K
Device Expiration Date2019-03-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMMJ SA DE CV (USD)
Manufacturer AddressAVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-04

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