MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-07 for MCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM manufactured by Medspira Llc.

MAUDE Entry Details

Report NumberMW5087234
MDR Report Key8683962
Date Received2019-06-07
Date of Report2019-06-05
Date of Event2019-06-04
Date Added to Maude2019-06-10
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 NameMCOMPASS MANOMETRIC BIOFEEDBACK SYSTEM
Generic NameDEVICE, BIOFEEDBACK
Product CodeHCC
Date Received2019-06-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDSPIRA LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-07

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