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 report with the FDA on 2017-09-28 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.

Event Text Entries

[87632889]
Patient Sequence No: 1, Text Type: N, H10


[87632890] Medtronic received communication from customer alleging rash on patient where sensor was applied. Customer was unable to provide additional information regarding the circumstances of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2017-05505
MDR Report Key6900741
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-09-28
Date of Report2017-08-31
Date of Event2017-06-28
Date Mfgr Received2017-08-31
Date Added to Maude2017-09-28
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 ContactSHARON MURPHY
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone2034925267
Manufacturer G1CELESTICA ELECTRONICS S PTE LTD
Manufacturer StreetNO. 6 SERANGOON NORTH AVENUE 5
Manufacturer CitySINGAPORE 554910
Manufacturer CountrySG
Manufacturer Postal Code554910
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIS
Generic NameELECTRODE, CUTANEOUS
Product CodeGXY
Date Received2017-09-28
Model Number186-0106
Catalog Number186-0106
Lot NumberUNKNOWN
Device Expiration Date2014-05-15
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
101. Other 2017-09-28

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