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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 07/13/2022

Event Type  Injury  

Event Description

Went to er for what was thought appendicitis, found out my filshie clip has migrated and was sitting on my kidney.Clip now migrates around my body causing extreme pain and sickness.Will have surgery monday to remove other clip.If the migrating clip cannot be found, i was told they will leave it in my body for the rest of my life.This is not okay and filshie clips should be stopped due to hundreds of other women dealing with the same issues."filshie himself" did a study that 25% of the researched women had this happened, that's 1 in 4 women and it somehow still got approved? everything was negative except for the clip migrating.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: 15104649
• MDR Text Key: 296688712
• Report Number: MW5111109
• 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: 07/21/2022

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: 07/25/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White