AMVEX FMAA#####XX FMAA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-11 for AMVEX FMAA#####XX FMAA manufactured by Ohio Medical.

MAUDE Entry Details

Report Number8990989
MDR Report Key8990989
Date Received2019-09-11
Date of Report2019-08-12
Date of Event2019-07-31
Report Date2019-08-15
Date Reported to FDA2019-08-15
Date Reported to Mfgr2019-09-11
Date Added to Maude2019-09-11
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMVEX
Generic NameFLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
Product CodeCAX
Date Received2019-09-11
Returned To Mfg2019-08-15
Model NumberFMAA#####XX
Catalog NumberFMAA
Lot NumberUNKNOWN
Device AvailabilityR
Device Age2 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL
Manufacturer Address1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-11

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