MAUDE Adverse Event Report: FEMCARE LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Pain (1994)

Event Date 12/07/2019

Event Type  Injury  

Event Description

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).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 9671472
• MDR Text Key: 177968328
• Report Number: MW5092758
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 33 YR