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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Headache (1880); Pain (1994); No Code Available (3191)
Event Date 10/25/2018
Event Type  Injury  
Event Description
I had filshie clips placed in 2012 without my knowledge.I recently made an emergency room visit with severe abdominal pain in my left side.The emergency room (er) doctor after ordering tests and ct scan discovered i had a migrated filshie clip in my left abdominal wall causing the pain.I've had many issues since my tubal ligation and was unable to explain the issues such as being diagnosed with a autoimmune disease about 6 months after the surgery.I've had hormonal imbalance, sever headaches and pain in my pelvic and thigh region and was being unaware of these clips having learned they could be responsible.I was told by my obgyn i was having my tubes cut and burnt but like i said learned there were clips placed.My doctor who is responsible has recently moved and i am having no luck getting it removed or fixed.
 
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Brand Name
FILSHIE CLIP
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
MDR Report Key8071197
MDR Text Key127339649
Report NumberMW5081275
Device Sequence Number1
Product Code KNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age33 YR
Patient Weight150
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