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 2019-12-31 for FILSHIE CLIP manufactured by Femcare Ltd..

Event Text Entries

[173502188] I had a schedule c-section followed by tubal ligation, i specified no clips. To my horror a few years later an x-ray showed surgical clips and my most current ct scan shows the clips have migrated and is the only possible cause to my severe abdominal pain. I found out they used filshie clips and thousands of other women have dealt with being unaware they had them until migration and complications along with post tubal ligation syndrome. Filshie clips need to have a warning and drs need to really sit down with their pts and explain everything to them. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5091966
MDR Report Key9539118
Date Received2019-12-31
Date of Report2019-12-27
Date of Event2011-07-25
Date Added to Maude2020-01-02
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 Report3

Device Details

Brand NameFILSHIE CLIP
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Product CodeKNH
Date Received2019-12-31
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFEMCARE LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-12-31

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