MONOJECT 8881540111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-10 for MONOJECT 8881540111 manufactured by Cardinal Health, Inc..

MAUDE Entry Details

Report Number9174158
MDR Report Key9174158
Date Received2019-10-10
Date of Report2019-10-09
Date of Event2019-10-04
Report Date2019-10-09
Date Reported to FDA2019-10-09
Date Reported to Mfgr2019-10-10
Date Added to Maude2019-10-10
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 OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMONOJECT
Generic NameCANNULA, SURGICAL, GENERAL PLASTIC SURGERY
Product CodeGEA
Date Received2019-10-10
Returned To Mfg2019-10-09
Model Number8881540111
Catalog Number8881540111
Lot Number923832
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH, INC.
Manufacturer Address1222 SHERWOOD RD NORFOLK NE 68701 US 68701


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-10

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