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

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 09/15/2020

Event Type  Injury  

Event Description

I had filshie clips for sterilization in (b)(6) of 2017.I went in to have my tubes removed, but after surgery i found out they put on filshie clips.I became pregnant in (b)(6) of 2020 and delivered the baby via c-section in (b)(6) 2020.I had them remove my tubes at that time.One filshie clip was still attached and they removed it.The one on my right side was missing and they couldn't recover it.I am now having pelvic pain on my right side.I plan to see a doctor about it soon.I was (b)(6) at deliver and my husband (b)(6).We love our baby, but it's not something we expected late in life and it has changed our lives forever.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 14488695
• MDR Text Key: 292611277
• Report Number: MW5109880
• 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: 05/20/2022

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: 05/23/2022
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICINE
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White