VAPR 227504

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for VAPR 227504 manufactured by Depuy Mitek, Llc.

MAUDE Entry Details

Report Number9391786
MDR Report Key9391786
Date Received2019-11-29
Date of Report2019-11-20
Date of Event2019-05-15
Report Date2019-11-20
Date Reported to FDA2019-11-20
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVAPR
Generic NameELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
Product CodeGEI
Date Received2019-11-29
Model Number227504
Catalog Number227504
Lot NumberU1810144
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK, LLC
Manufacturer Address325 PARAMOUNT DR RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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