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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hair Loss (1877); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Anxiety (2328); Abdominal Cramps (2543); Confusion/ Disorientation (2553); Abdominal Distention (2601)

Event Date 05/03/2017

Event Type  Injury  

Event Description

I opted for tubal ligation.Requested no devices / implants / clips / coils etc.Dr "forgot" and placed filshie clips regardless.Immediately and ever since, i have suffered menstrual irregularity (complete absence of periods for 16 months even after complete wearing from breastfeeding, followed by erratic cycles ranging from 10 days to 55 days, and lasting as long as 2 to 3 weeks each, some but not all), severe hot flashes accompanied by waves of nausea, extreme hair loss by about half, thicker and new black body hair elsewhere, severe mood swings and mental health symptoms (including anxiety, insecurity, poor self image, unhealthy body obsession and subsequent dieting / disordered eating, crying spells, rage), abdominal bloating to appear 2nd trimester pregnant in spite of losing all baby weight plus some, abdominal pain ranging from dull achy "fullness / heaviness" to crampy sharp pain, mental cloudiness, distraction, forgetfulness, inability to concentrate / focus.These symptoms peak in waves, i do have normal days where i feel more or less ok, but more days than not, i experience these symptoms to varying degrees.I am (b)(6) y/o, and prior to the surgery i had normal cycles, excellent fertility, and minimal premenstrual symptoms.I gave birth to a full term girl, and then conceived my last (fifth) baby on the second cycle once i weaned her enough for cycles to resume.I am 100% convinced this is not normal perimenopause, as women in my family tend to start experiencing these symptoms near or after 50; 12 yrs early is a long time to suffer these symptoms, and while caring for babies /toddlers simultaneously is extremely difficult.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD.
• MDR Report Key: 8208668
• MDR Text Key: 132206569
• Report Number: MW5082743
• 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: 12/28/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 61