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

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Menstrual Irregularities (1959); Foreign Body In Patient (2687)

Event Date 04/28/2023

Event Type  Injury  

Event Description

I have been experiencing abdominal pain from my groin area up to my floating ribs for at least 3 years i finally got a ct scan at my most recent hospital visit where they found my filshie clip is no longer intact and is floating in my body i have no idea how long this has been an issue but i imagine it was probably a year after my procedure which was 7 years ago ever since then i have experienced debilitating pain and abnormal female cycles i believe this has greatly impacted my day-to-day living.Please don't let this keep happening to people my daily life is greatly impacted but this malfunctioning device.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 16888528
• MDR Text Key: 314869369
• Report Number: MW5117365
• 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: 05/03/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Patient Sequence Number: 1
• Treatment: LAMOTRIGINE.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White, American Indian Or Alaskan Native