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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Swollen Lymph Nodes/Glands (4432)

Event Date 08/19/2021

Event Type  Injury  

Event Description

Thirteen (13) years after my filshie clips were placed a swollen lymphnode appeared in left filshie clip area.I began having severe stabbing pains in my pelvic, uterus, cervix, and hips.Then i started bleeding bright red blood inbetween periods.Problem was removed after device was removed.I had issues with device in beginning they just weren't as major and my dr didn't attribute my cervical pain to the clips and i now do.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL / FEMCARE LTD.
• MDR Report Key: 13938886
• MDR Text Key: 288206907
• Report Number: MW5108579
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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): Disability; Required Intervention; Hospitalization; Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White