DISPOSABLE CHECK-FLO ADAPTER 050885 G15476

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for DISPOSABLE CHECK-FLO ADAPTER 050885 G15476 manufactured by Cook Inc..

MAUDE Entry Details

Report NumberMW5090710
MDR Report Key9245136
Date Received2019-10-25
Date of Report2019-10-10
Date of Event2019-01-23
Date Added to Maude2019-10-28
Event Key0
Report Source CodeVoluntary 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 Report0

Device Details

Brand NameDISPOSABLE CHECK-FLO ADAPTER
Generic NameLAPAROSCOPE, GYNECOLOGIC
Product CodeHET
Date Received2019-10-25
Catalog Number050885 G15476
Lot Number9193929
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.