FILSHIE CLIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-10 for FILSHIE CLIP manufactured by Femcare Ltd.

MAUDE Entry Details

Report NumberMW5089719
MDR Report Key8992700
Date Received2019-09-10
Date of Report2019-09-08
Date of Event2019-09-05
Date Added to Maude2019-09-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
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 CLIP
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
Product CodeKNH
Date Received2019-09-10
Device Expiration Date2017-01-01
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFEMCARE LTD

Device Sequence Number: 2

Brand NameFILSHIE CLIP
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
Product CodeKNH
Date Received2019-09-10
Device Expiration Date2017-01-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerFEMCARE LTD

Device Sequence Number: 3

Brand NameFILSHIE CLIP
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
Product CodeKNH
Date Received2019-09-10
Device Expiration Date2017-01-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerFEMCARE LTD

Device Sequence Number: 4

Brand NameFILSHIE CLIP
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
Product CodeKNH
Date Received2019-09-10
Device Expiration Date2017-01-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerFEMCARE LTD


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2019-09-10

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