FILSHIE TUBAL LIGATION SYSTEM AVM-851

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-21 for FILSHIE TUBAL LIGATION SYSTEM AVM-851 manufactured by Coopersurgical.

MAUDE Entry Details

Report NumberMW5090551
MDR Report Key9219980
Date Received2019-10-21
Date of Report2019-10-18
Date of Event2019-10-16
Date Added to Maude2019-10-22
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 Sequence Number: 1

Brand NameFILSHIE TUBAL LIGATION SYSTEM
Generic NameFILSHIE CLIPS
Product CodeKNH
Date Received2019-10-21
Catalog NumberAVM-851
Lot Number35041
Device Expiration Date2017-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL
Manufacturer AddressUS

Device Sequence Number: 2

Brand NameFILSHIE TUBAL LIGATION SYSTEM
Generic NameFILSHIE CLIPS
Product CodeKNH
Date Received2019-10-21
Catalog NumberAVM-851
Lot Number35041
Device Expiration Date2017-09-30
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCOOPERSURGICAL
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-21

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