MAUDE Adverse Event Report: FEMCARE LTD FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994); Burning Sensation (2146)

Event Date 01/19/2011

Event Type  Injury  

Event Description

Lots of abdominal pain, heavy bleeding, large blood clots, stabbing pain in my left side, pulling feeling near my bellybutton, experiencing a burning sensation near my left ovary; i was not told anything about filshie clips being used.It wasn't until 1 year later that i found out that i had filshie clips due to an x-ray that i needed for a kidney stone.These clips have caused me to have severely bad pain and i regret getting my tubes done.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD
• MDR Report Key: 8504085
• MDR Text Key: 141769743
• Report Number: MW5085792
• 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: 04/08/2019

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 100