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

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

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Emotional Changes (1831); Hair Loss (1877); Hemorrhage/Bleeding (1888); Scar Tissue (2060); Thrombus (2101); Vomiting (2144); Hot Flashes/Flushes (2153); Weight Changes (2607)

Event Date 03/07/2008

Event Type  Injury  

Event Description

The first incident happened on (b)(6) 2008, and was recurring to this present day (b)(6) 2019.I had severe lower stomach pains that caused my entire body to shake uncontrollably and i vomited from the pain being so intense.This happened several times and the doctor informed me that i was having cysts that would burst.Due to the amount of pain i was constantly in, i ended up with high blood pressure.When a sonogram was done of my ovaries, they were filled with cysts and i never had any before the filshie clips.I ended up having severe periods with bleeding and golf ball sized blood clots.The doctor recommended having a uterine ablation to see if that would help with the heavy bleeding.It didn't help much.A year later i requested to have the tubes removed and i ended up having to get a salpingectomy due to the amount of scar tissue that was there.The filshie clips were no longer attached my fallopian tubes, but thankfully the doctor was able to find them and remove them.Another side effect i had with these clips was the weight gain.I was never an overweight person, but after these clips were put in, i gained 80 lbs and no amount of exercise or changed eating habits has been able to change that.I've read that the clips can alter your hormones and send you into early menopause.I have had hot flashes, loss of hair, moodiness, reduced sex drive and vaginal dryness.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE - NIKOMED LTD.
• MDR Report Key: 8231419
• MDR Text Key: 132841403
• Report Number: MW5082972
• 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: 01/07/2019

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: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 25 YR
• Patient Weight: 91