SURE-T? PARADIGM?

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 SURE-T? PARADIGM? manufactured by .

MAUDE Entry Details

Report Number3003442380-2019-01945
MDR Report Key9392209
Report SourceDISTRIBUTOR
Date Received2019-11-30
Date Mfgr Received2019-10-31
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 NameSURE-T? PARADIGM?
Generic NameCONTACT DETACH G29 80/6 PCC
Product CodeFPA
Date Received2019-11-30
Lot Number5278544
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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