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

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Pain (1994); Burning Sensation (2146); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Foreign Body In Patient (2687)

Event Date 06/27/2018

Event Type  Injury  

Event Description

I had the filshie clips applied in 2018.Since then i have been suffering from anxiety/depression, burning pain in vagina, frequent urination with no infection and one of the clips had migrated to my upper left abdomen.I have had chronic abdominal and back pain for the last month, yet the drs are not concerned with the clip lodged near my kidney/liver.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 7650594
• MDR Text Key: 112882785
• Report Number: MW5078173
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/27/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 84