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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Autoimmune Reaction (1733); Fatigue (1849); Headache (1880); Inflammation (1932); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Abdominal Distention (2601); Constipation (3274)

Event Date 09/05/2019

Event Type  Injury  

Event Description

Four filshie clips in my abdomen from a failed tubal ligation.It has been causing severe abdominal pain, slightly enlarged spleen as of (b)(6).I was admitted for observation due to abdominal pain and suspected gallbladder issues, released later that day because "no reason" for pain and symptoms besides possibility of clips.One clip located in the left upper quadrant, 1 on the lower bowel area, 1 in pouch douglass, and 1 near the bladder.I have had severe bloating, nausea, pain, constipation, headaches, fatigue, absent menses, painful sex, vaginal prolapse, signs of internal organ inflammation, and body aches.Suspected auto-immune issues, currently with rheumatology to monitor outpatient, see if clips are causing all the symptoms.I had a tubal in (b)(6) 2017, using these clips, and didn't know of their migration until (b)(6) 2019.I had an auto immune panel done in (b)(6) 2019, it showed inflammation but no other diseases, besides fibromyalgia, i intend to have all 4 clips removed from my abdomen, but need to find a general surgeon willing to do this complicated of an abdominal surgery.Willing to give fda the clips after removal for study.All of the clips were proven to still be closed, meaning the tube died, in order for the clips to fall off and migrate.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): FEMCARE LTD
• MDR Report Key: 8992700
• MDR Text Key: 158638267
• Report Number: MW5089719
• 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: 09/08/2019
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Device Expiration Date: 01/01/2017
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 25 YR
• Patient Weight: 86