MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-30 for MIO? manufactured by .

MAUDE Entry Details

Report Number3003442380-2019-01950
MDR Report Key9392202
Date Received2019-11-30
Date Mfgr Received2019-11-01
Date Added to Maude2019-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer StreetAAHOLMVEJ 1-3 OSTED
Manufacturer CityLEJRE, 4320
Manufacturer CountryDA
Manufacturer Postal4320
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIO?
Generic NameINSET II 46/6 PCC BLUE
Product CodeFPA
Date Received2019-11-30
Lot Number5259959
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patient NumberTreatmentOutcomeDate
10 2019-11-30

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.