5MM MARYLAND JAW SEALER/DIVIDER, 37CM COVLF1737

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-23 for 5MM MARYLAND JAW SEALER/DIVIDER, 37CM COVLF1737 manufactured by Sterilmed, Inc..

MAUDE Entry Details

Report Number2134070-2019-00141
MDR Report Key8819731
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-23
Date of Report2019-06-29
Date of Event2019-06-25
Date Mfgr Received2019-07-29
Device Manufacturer Date2018-06-14
Date Added to Maude2019-07-23
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 ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DR
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9497898687
Manufacturer G1STERILMED, INC.
Manufacturer Street5010 CHESHIRE PARKWAY STE 2
Manufacturer CityPLYMOUTH MN 55446
Manufacturer CountryUS
Manufacturer Postal Code55446
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5MM MARYLAND JAW SEALER/DIVIDER, 37CM
Generic NameELECTROSURGICAL, CUT & COAG ACCESSORY, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
Product CodeNUJ
Date Received2019-07-23
Returned To Mfg2019-07-29
Catalog NumberCOVLF1737
Lot Number2046675
Device Expiration Date2019-06-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer Address5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-23

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