BIS 186-0106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-10-14 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.

MAUDE Entry Details

Report Number2936999-2019-00863
MDR Report Key9188775
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2019-10-14
Date of Report2019-10-14
Date of Event2019-09-25
Date Mfgr Received2019-09-25
Date Added to Maude2019-10-14
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 G1CELESTICA ELECTRONICS S PTE LTD
Manufacturer StreetNO. 6 SERANGOON NORTH AVENUE 5
Manufacturer CitySINGAPORE 554910
Manufacturer CountrySG
Manufacturer Postal Code554910
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIS
Generic NameELECTRODE, CUTANEOUS
Product CodeGXY
Date Received2019-10-14
Model Number186-0106
Catalog Number186-0106
Lot Number1209181K
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCELESTICA ELECTRONICS S PTE LTD
Manufacturer AddressNO. 6 SERANGOON NORTH AVENUE 5 SINGAPORE 554910 SG 554910


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-14

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