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

Catalog Number #AVM

Device Problem Use of Device Problem (1670)

Patient Problems Fatigue (1849); Nausea (1970); Pain (1994); Vomiting (2144); Weight Changes (2607); Genital Bleeding (4507)

Event Date 12/01/2022

Event Type  Injury  

Event Description

I had a tubal ligation with filshie clips in 2008.I have since had painful and heavy periods over the following years.In 2017 i became extremely ill with symptoms such as nausea, vomiting, weight loss, food intolerance, unexplained severe pelvic and abdominal pain, brain fog and constant fatigue.I had all tested done and they could not find anything wrong except my clips weren't present on my right side.No one would admit it could be the migrated dislodged clips.I am also very allergic to metal and my white blood count is extremely high because these clips are causing my body to respond as if i have severe inflammation and infection.Five years of suffering later i know have back pain and have gotten new image that show the remaining visible clips have flipped and fallen down even lower.My insurance will not pay for exploratory surgery to remove them and no one in the medical field will admit they are dangerous far beyond what they claim, i fear these will kill me.Please take them off the market.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD
• MDR Report Key: 16771141
• MDR Text Key: 313660674
• Report Number: MW5116835
• 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: 04/14/2023

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
• Device Catalogue Number: #AVM
• Device Lot Number: 851
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Patient Sequence Number: 1
• Treatment: GABAPENTIN; IBUPROPEN; MUSCLE RELAXANT
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White