MYOCYCLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for MYOCYCLE manufactured by Myolyn.

Event Text Entries

[101646536] Purchased myocycle from myolyn. Cycle is defective - keeps stopping while i ride. Seems like it cannot be fixed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075622
MDR Report Key7312974
Date Received2018-03-01
Date of Report2018-02-27
Date of Event2018-02-26
Date Added to Maude2018-03-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 NameMYOCYCLE
Generic NameSTIMULATOR, NEUROMUSCULAR
Product CodeGZI
Date Received2018-03-01
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMYOLYN


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-01

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