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

Device Problem Migration (4003)

Patient Problems Fatigue (1849); Menstrual Irregularities (1959); Pain (1994); Abdominal Distention (2601); Dyspareunia (4505); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/21/2018

Event Type  Injury  

Event Description

I had filshie clips played in 2014 after my 4th c-section.In 2018 i started to have extreme pelvic pain resulting in an emergency room visit.The doctor did a pelvic exam and ultra sound.The ultra sound revealed fibroids and thickening if the uterus wall.I never had any of these issues prior.Another visit in 2020 showed one clip in my paracolic fat.I have been suffering for years without any relief.Most recent ultrasound shows my uterus enlarged and a fibroid.Since i have gotten these clips i have had shooting pains, stabbing pains, abdominal swelling, irregular menstrual cycles, fatigue, and painful intercourse.I regret ever having these clips placed knowing the effects they are causing me and many others.Fda safety report id # (b)(4).

Event Description

I had filshie clips played in 2014 after my 4th c-section.In 2018 i started to have extreme pelvic pain resulting in an emergency room visit.The doctor did a pelvic exam and ultra sound.The ultra sound revealed fibroids and thickening if the uterus wall.I never had any of these issues prior.Another visit in 2020 showed one clip in my paracolic fat.I have been suffering for years without any relief.Most recent ultrasound shows my uterus enlarged and a fibroid.Since i have gotten these clips i have had shooting pains, stabbing pains, abdominal swelling, irregular menstrual cycles, fatigue, and painful intercourse.I regret ever having these clips placed knowing the effects they are causing me and many others.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• MDR Report Key: 13506721
• MDR Text Key: 285490021
• Report Number: MW5107374
• 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: 02/07/2022

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White