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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/13/2023

Event Type  Injury  

Event Description

I'm not sure if the dates are correct.I'm going to a surgeon next week but i was told that one of the filshie clips came loose and is pushing on my small intestines, causing groin pain in that area.I believe i've had this problem for awhile because i had similar pain in my stomach area and i've had a few xrays where they would ask me about the clip.Hopefully i can have it removed because it's been causing quite a bit of pain lately.

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 18457397
• MDR Text Key: 332305206
• Report Number: MW5149865
• 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: 01/02/2024

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: 01/04/2024
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White