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

Device Problem Defective Device (2588)

Patient Problem Pregnancy with a Contraceptive Device (4517)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Became pregnant with filshie clips.Many issues with migrating from other women.Unfortunately because of my failed sterilization resulting in the pregnancy, i cannot have tests done just yet to see if they've migrated or if they are still attached to my tubes.This product should not be on the market or be inserted in women if (for one) it's ineffective (for two) it doesn't prevent pregnancy at the rate it claims.Something needs to be done.There are (b)(6) groups of multiple women who have these same problems of either falling pregnant or mainly the clips migrating to other places including the spine, embedding in organs, causing pain and discomfort.Please do something.This isn't right and our health is at risk.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: 13929362
• MDR Text Key: 288116030
• Report Number: MW5108538
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White