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

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Adhesion(s) (1695); Autoimmune Disorder (1732); Erosion (1750); Connective Tissue Disease (1786); Headache (1880); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Rash (2033); Ambulation Difficulties (2544); Weight Changes (2607); Swelling/ Edema (4577)

Event Date 04/10/2006

Event Type  Injury  

Event Description

I, (b)(6), who is 41-year of age, am requesting compensation due to the migration of the left filshie clip attached to the anterior fold of the uterus behind the bladder, which caused dense adhesions of the sigmoid colon to the posterior uterus from the left cornua to the right cornu.Dr.(b)(6), removed left filshie clip-on on (b)(6) 2022.(b)(6)2003, dr.(b)(6), laparoscopic bilateral tubal ligation using filshie clips, manufactured by cooper surgical inc.2006, right filshie clip dislodged and eroded through the tube, and laparoscopy surgery was performed on (b)(6) 2006, to retrieve the right filshie clip and repair the right tube.I will not be requesting compensation for the right clip migration on (b)(6)2006, due to no downtime from work and no severe complications.(b)(6)2021, my primary doctor dr.(b)(6), condemned me as wholly disabled and not cleared to work.Due to the migration, right filshie clip was attached to the anterior fold of the uterus behind the bladder, which caused dense adhesions of the sigmoid colon to the posterior uterus from the left cornua all the way to the right cornu.Which caused me to have severe bladder infections, ana positive connective tissue disease, ana titer, butterfly rash on face across cheeks and nose, increase weight gain due to the swelling, fluid, and connective tissue disease and severe chronic pain and swelling of my.Left lower spine, hip, and left lower ankle swelling at times as well as high spinal taps over 30s, severe chronic migraines that kept me in bed 3 to 4 times out of the week and left me limping, constantly loosen balance/ fallen and not able to sit or stand over 30 minutes without my lower pelvic and lower left spine swelling and hurting in severe pain.It has been 14 days since the right filshie clip was removed.As of today, (b)(6)2022, i am still suffering from ana positive connective tissue disease and severe migraines that keep me in bed 3 to 4 times a week.Not able to sit or stand for over 30 minutes without my lower left pelvic, spine, hip swelling, and butterfly rash on my face across cheeks and nose.Uncontrollable leaking bladder issues, pain, and discomfort.Incontinence of bowel issues.To date, (b)(6) has suffered $839,722.50 in special damages.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE, LTD
• MDR Report Key: 17525265
• MDR Text Key: 321142443
• Report Number: MW5132206
• 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: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1