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 2020-02-06 for FILSHIE CLIP manufactured by Femcare Ltd.

Event Text Entries

[178348687] On (b)(6) 2018 until (b)(6) 2018 i had multiple tests, exams and exploratory surgery to find only one filshie clip. I then had to have more tests, exams and a second exploratory surgery to find the second filshie clip in (b)(6) 2019. It resulted in losing my right fallopian tube and ovary. I had a slew of tests to try and find what was causing all my pain and urinary symptoms.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092831
MDR Report Key9681806
Date Received2020-02-06
Date of Report2020-02-04
Date Added to Maude2020-02-07
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 Received2020-02-06
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFEMCARE LTD


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2020-02-06

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