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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Malaise (2359); Foreign Body In Patient (2687)

Event Date 05/10/2022

Event Type  Injury  

Event Description

Right filshie clip broke with a piece of metal stuck inside my tube.Left clip is fine but my body doesn't know if i'm pregnant or not.I haven't felt good in 6-7 months and i have had them for 8 years with not a problem.I just want to feel better.I don't like being pregnant that's why i hat them tied.It did know till my follow up after birth for my son.Something is in the right tube but too soon to tell.Every time i go to the hospital and get discharged the dr is putting my life in danger because they won't listen to me.I've had 2 baby's and miscarriage, i know my body.

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 16158181
• MDR Text Key: 307498221
• Report Number: MW5114326
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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): Disability
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White