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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 i went to the er for abdominal pain and discovered via ct scan that the filshie clip on from the left tube had migrated and is lodged in my spleen.At this time i am unsure if my general surgeon is going to risk the life threatening complications to remove it.Two gynecologists have told me that filshie clips commonly migrate, which was never mentioned prior to my tubal ligation.One of those doctors refused to report migration to the fda as an adverse event so i think your date is severely flawed.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL/FEMCARE LTD.
• MDR Report Key: 9570364
• MDR Text Key: 174666016
• Report Number: MW5092136
• 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: 01/07/2020

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: 01/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 73