BUGBEE ELECTRODE UNIT 5716174

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-28 for BUGBEE ELECTRODE UNIT 5716174 manufactured by .

MAUDE Entry Details

Report Number8775154
MDR Report Key8775154
Date Received2019-06-28
Date of Report2019-06-21
Date of Event2019-06-19
Date Facility Aware2019-06-19
Report Date2019-06-21
Date Reported to Mfgr2019-06-21
Date Added to Maude2019-07-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBUGBEE ELECTRODE
Generic NameMONOPOLAR FLEXIBLE ELECTRODE
Product CodeFAS
Date Received2019-06-28
Model NumberUNIT 5716174
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
Manufacturer AddressV. MUELLER RD FRANKLIN LAKES NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-28

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