MAUDE Adverse Event Report: FEMCARE-NIKOMED LTD FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Thrombus (2101)

Event Date 01/22/2010

Event Type  Injury  

Event Description

Not reversible as described.Six weeks after having the birth of my second child i received tubal ligation by filshie clips which risks were seriously downplayed and i was made to believe that negative side effects far and few between.I asked many questions and i was convinced that this product been well-researched and on the market for quite some time.Set the negative risk i would be taking but having this device inside me was portrayed in a way seemingly to be non-existent and could be reversed at anytime without the side effects or damage of traditional tubal ligation as well as healing time would be minimal and surgery is non-invasive since i've had them put on i've had blood clots, cluster migraines, extremely painful periods, extreme fatigue all during my twenties.It's been 10 years since i've had them put on and spent the majority of my last decade in bed because of pain, hurting too bad to not only provide for myself and hold a job but some days so bad i can't even shower.I still have my original pictures they gave me of my filshie clips inside me but i much rather not submit that picture.Fda safety report id #: (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD
• MDR Report Key: 10104985
• MDR Text Key: 194027040
• Report Number: MW5094762
• 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: 05/27/2020

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 20 YR