FILSHIE CLIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for FILSHIE CLIPS manufactured by Femcare Ltd..

Event Text Entries

[176035571] I had filshie clips put in a week after (b)(6) 2015 and had one of the clips shred my right fallopian tube and attach itself to my bowel wall; i was told if i would have moved just right i would have ripped a hole in my wall and gone septic. I had my ob/gyn removed the clips. Later in 2017 i had a hysterectomy due to continuous pain from being torn to shreds. Fda safety report id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092362
MDR Report Key9610794
Date Received2020-01-17
Date of Report2020-01-15
Date of Event2016-09-20
Date Added to Maude2020-01-21
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 CLIPS
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Product CodeKNH
Date Received2020-01-17
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFEMCARE LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-01-17

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