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

Model Number AVM-851

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Chest Pain (1776); Menstrual Irregularities (1959); Pain (1994)

Event Date 08/15/2021

Event Type  Injury  

Event Description

I had tubal ligation clips (filshies) implanted at the birth of my third child on (b)(6) 2015.I did not know they implanted anything in me.I believed they were just tying them.Immediately following my periods became very heavy and painful.This was never an issue before.In 2016 i was prescribed and still take birth control pills to not have periods.Not having to take the pill had been my primary objection in getting my tubes tied to begin with.Then in (b)(6) of 2021, i began having severe chest, upper back and left arm pain.In (b)(6) of 2021 i had a series of xrays and a ct scan that showed that my left clip had migrated to my upper left quadrant.It is sitting in or around my spleen and now has to be removed.All of this has come at cost to my quality of life and pocket book.Fda safety report id# (b)(4).

• Brand Name: CLIP TUBAL LIGATION FILSHIE
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL INC. / FEMCARE LTD.
• MDR Report Key: 13019038
• MDR Text Key: 282398244
• Report Number: MW5106083
• 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: 12/13/2021

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 Model Number: AVM-851
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Patient Sequence Number: 1
• Treatment: SPRINTEC (BIRTH CONTROL)
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White