MAUDE Adverse Event Report: FEMCARE-NIKOMED FILCHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Fatigue (1849); Hair Loss (1877); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Burning Sensation (2146); Hot Flashes/Flushes (2153); Myalgia (2238); Sweating (2444); Heavier Menses (2666)

Event Date 06/15/2011

Event Type  Injury  

Event Description

Ptls, anal cyst, confusion; my issue started shortly after the implementation of the filshie clips.Which i was told by the doctor they were not permanent.I had no prior medical condition that called for permanent sterilization.I had three c-sections with no complications during pregnancy.Proximately a year after i started experiencing heavy menstrual flow that was treated by pill form contraceptions.Recently in the last 5 years the bleeding has gotten worse to the point that i can't leave the house for about 5 days and followed by 6 days of spotting, i am also experiencing lapse in memory, confusion, anxiety, anal and pelvic cysts, severe abdominal pain, fatigue, constant anal itching, pain during intercourse/ masturbation, diarrhea, facial hair, pubic hair loss, burning sensation on my back and legs, night sweats, hot flashes, restless leg syndrome, and short attention span.I have had my hormone levels checked they have all came back normal.I also had two ultrasounds done and both are contradicting one another.The only option that the doctors are giving me is a complete and full hysterectomy which will not fix the problem but cause my symptoms to worsen, to me experiencing post menopausal symptoms already.The filshie clips are causing my current medical issues not my reproductive organs.Fda safety report id# (b)(4).

• Brand Name: FILCHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED
• MDR Report Key: 10613351
• MDR Text Key: 209611862
• Report Number: MW5096994
• Device Sequence Number: 1
• Product Code: HHS
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient

Device Model Number

Device Lot Number

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 87