L300 GO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for L300 GO manufactured by Bioness.

Event Text Entries

[92869869] Brace burned skin. Causing pain and difficulty walking with already having difficulties hence the need for the brace.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073521
MDR Report Key7052417
Date Received2017-11-22
Date of Report2017-11-18
Date of Event2017-11-15
Date Added to Maude2017-11-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameL300 GO
Generic NameSTIMULATOR, NEUROMUSCULAR, EXTERNAL
Product CodeGZI
Date Received2017-11-22
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBIONESS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-22

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