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 2020-02-04 for FILSHIE CLIPS manufactured by Femcare Ltd..

Event Text Entries

[177968328] I had filshie clips placed in 2017, a decision unilaterally made by my dr that i did not consent to clips being left in my body. I began having severe abdominal and pelvic pain. The pain was especially severe on my right tube. It felt like a sword through my pelvis when i was active longer than an hour. The pain radiated down my right leg. I had scans show that my left clip had lodged into my spleen. I just underwent an operation to remove the clips, and the one on my spleen is too deep into the organ to remove without injury to the spleen. I have to choose between living without a spleen or living with a foreign body lodged in my spleen which causes pain and anxiety. The clip on my right tube was hanging on by a thread and dangling around my tube / uterus / ovary, no wonder i had so much pain every day. The dr was able to remove the right clip and the right side pelvic and leg pain has resolved 100%. I had a number of drs tell me the clip was not the cause of my pain, and now that it's gone i know for a fact it was caused by the clip. I still feel the clip in my spleen but am not ready to live without a spleen and the life threatening risks and complications from that. These should not be placed in women, every dr i saw acknowledges the extremely high rate of migration, it's a known fact. How can you allow such treatment of women? Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092758
MDR Report Key9671472
Date Received2020-02-04
Date of Report2020-01-01
Date of Event2019-12-07
Date Added to Maude2020-02-05
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 Received2020-02-04
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFEMCARE LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2020-02-04

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