MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for manufactured by .

MAUDE Entry Details

Report NumberCOR20000024-000
MDR Report Key9586809
Date Received2020-01-13
Date of Report2020-01-13
Date Added to Maude2020-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMr. Paul Merckx
Manufacturer StreetSeptestraat 27
Manufacturer CityMortsel B2640
Manufacturer CountryBE
Manufacturer PostalB2640
Manufacturer Phone3234447554
Manufacturer G1Agfa N.V.
Manufacturer StreetSeptestraat 27
Manufacturer CityMortsel B2640
Manufacturer CountryBE
Manufacturer Postal CodeB2640
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeKPR
Date Received2020-01-13
Device AvailabilityI
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-13

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