BIS 186-0106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-29 for BIS 186-0106 manufactured by Jabil Circuit(shanghai) Ltd.

Event Text Entries

[146462545] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[146462546] According to the reporter, after the procedure was completed, when the sensor was removed, burn-like symptom was seen that the patient's skin was whitish and swollen. After several hours of observation, the patient skin condition was not improved and the redness of the skin injury was not relieved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2019-00375
MDR Report Key8652509
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-05-29
Date of Report2019-05-29
Date of Event2019-05-09
Date Mfgr Received2019-05-09
Date Added to Maude2019-05-29
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 G1JABIL CIRCUIT(SHANGHAI) LTD
Manufacturer StreetNO 600 TIAN LIN RD
Manufacturer CitySHANGHAI 20023
Manufacturer CountryCN
Manufacturer Postal Code20023
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIS
Generic NameELECTRODE, CUTANEOUS
Product CodeGXY
Date Received2019-05-29
Model Number186-0106
Catalog Number186-0106
Device Expiration Date2014-05-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerJABIL CIRCUIT(SHANGHAI) LTD
Manufacturer AddressNO 600 TIAN LIN RD SHANGHAI 20023 CN 20023


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.