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

Device Problem Migration (4003)

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

Event Date 06/11/2020

Event Type  Injury  

Event Description

I received a filshie clip in 2006 and have had problems with unexplained pain and major issues with scar tissue build up in my abdomen.It shut down my gall bladder and caused me to lost both ovaries.My doctor said he's never seen so much scar tissue when the last ovary was removed.The clip consistently shows up on xrays as travelling through my body and i have had pain and hospital admissions several times, unexplained source.I absolutely believe it's the clip floating freely through my body.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL INC. / FEMCARE LTD.
• MDR Report Key: 10157740
• MDR Text Key: 195384711
• Report Number: MW5095000
• 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: 06/11/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 48 YR
• Patient Weight: 68