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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); No Code Available (3191)

Event Date 07/25/2011

Event Type  Injury  

Event Description

I had a schedule c-section followed by tubal ligation, i specified no clips.To my horror a few years later an x-ray showed surgical clips and my most current ct scan shows the clips have migrated and is the only possible cause to my severe abdominal pain.I found out they used filshie clips and thousands of other women have dealt with being unaware they had them until migration and complications along with post tubal ligation syndrome.Filshie clips need to have a warning and drs need to really sit down with their pts and explain everything to them.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: 9539118
• MDR Text Key: 173502188
• Report Number: MW5091966
• 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: 12/27/2019

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 33 YR
• Patient Weight: 75