FLEXLAB FLX

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 2019-11-29 for FLEXLAB FLX manufactured by Inpeco Sa.

MAUDE Entry Details

Report Number3010825766-2019-00010
MDR Report Key9391930
Report SourceDISTRIBUTOR
Date Received2019-11-29
Date of Report2019-11-29
Date Mfgr Received2019-10-30
Device Manufacturer Date2019-04-30
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS EVA BALZAROTTI
Manufacturer StreetVIA TORRACCIA 26
Manufacturer CityNOVAZZANO, 6883
Manufacturer CountrySZ
Manufacturer Postal6883
Manufacturer G1INPECO SPA
Manufacturer StreetVIA GIVOLETTO 15
Manufacturer CityVAL DELLA TORRE, 10040
Manufacturer CountryIT
Manufacturer Postal Code10040
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXLAB
Generic NameLABORATORY AUTOMATION SYSTEM
Product CodeCEM
Date Received2019-11-29
Model NumberFLX
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINPECO SA
Manufacturer AddressVIA TORRACCIA 26 NOVAZZANO, 6883 SZ 6883


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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