DURACLIP HEMOCLIP DC0235

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 2020-03-12 for DURACLIP HEMOCLIP DC0235 manufactured by Micro-tech(nanjing) Co.,ltd.

MAUDE Entry Details

Report Number3004837686-2020-00002
MDR Report Key9827545
Report SourceDISTRIBUTOR
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-02-03
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-12
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 ContactBECKY LI
Manufacturer StreetNO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU
Manufacturer CityNANJING, JIANGSU 210032
Manufacturer CountryCH
Manufacturer Postal210032
Manufacturer G1MICRO-TECH(NANJING) CO.,LTD
Manufacturer StreetNO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU
Manufacturer CityNANJING, JIANGSU 210032
Manufacturer CountryCH
Manufacturer Postal Code210032
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURACLIP HEMOCLIP
Generic NameHEMOSTATIC METAL CLIP FOR THE GI TRACT
Product CodePKL
Date Received2020-03-12
Catalog NumberDC0235
Lot NumberM190905231
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMICRO-TECH(NANJING) CO.,LTD
Manufacturer AddressNO.10 GAOKE THIRD ROAD NANJING NATIONAL HI-TECH, INDU NANJING, JIANGSU 210032 CH 210032


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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