RELI BFN18G101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for RELI BFN18G101 manufactured by Micsafe Medical Group (china) Co. Inc..

MAUDE Entry Details

Report Number1058382-2019-00007
MDR Report Key9547460
Date Received2020-01-03
Date of Report2020-01-03
Date of Event2019-12-12
Date Facility Aware2019-12-20
Report Date2020-01-03
Date Reported to FDA2020-01-03
Date Reported to Mfgr2019-12-20
Date Added to Maude2020-01-03
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRELI
Generic NameBLUNT FILL NEEDLE
Product CodeGAA
Date Received2020-01-03
Catalog NumberBFN18G101
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICSAFE MEDICAL GROUP (CHINA) CO. INC.
Manufacturer Address802-805, BUILDING 6 NO.1678 JINGSHAJIANG RD. SHANGHAI, 200333 CH 200333


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-03

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