CLEARIFY 21-345

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 CLEARIFY 21-345 manufactured by Covidien Lp.

MAUDE Entry Details

Report Number9391749
MDR Report Key9391749
Date Received2019-11-29
Date of Report2019-11-22
Date of Event2019-11-05
Report Date2019-11-22
Date Reported to FDA2019-11-22
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 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 NameCLEARIFY
Generic NameLAPAROSCOPE, GENERAL PLASTIC SURGERY
Product CodeGCJ
Date Received2019-11-29
Model Number21-345
Catalog Number21-345
Lot NumberP8J1606X
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.