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

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Inadequate Pain Relief (2388)

Event Date 05/01/2019

Event Type  Injury  

Event Description

My doctor recommended filshie clips for tubal ligation.I asked to have my tubes tied but she pushed the clips.Almost immediately after getting them, i started having pain.I went back to the dr.And she said it wasn't the clips.I went to 5 doctors in a year.They all said "it was ibs" or "just my period".I knew it was from the filshie clips but no one would listen.They prescribed me medications i didn't need and ibuprofen that didn't help.Finally a dr.Listened and found that both the clips had migrated into my uterus.I asked to have the clips and the dr.Refused to give them to me.I can't file a lawsuit until you remove them from the market.I'm not alone.Thousands of women have gone through the same thing or worse.I still experience excruciating pain a year after removal from scarring.Do the right thing for us who are still suffering.Never tested for ibs.Avalon medical corporation.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 12985187
• MDR Text Key: 282218147
• Report Number: MW5105977
• 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: 12/08/2021
• 2 Devices were Involved in the Event: 1 2

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2021
• Patient Sequence Number: 1
• Treatment: MULTI VITAMIN
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Hispanic
• Patient Race: White