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

Device Problem Migration (4003)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Pain (1994); Inadequate Pain Relief (2388); Abdominal Distention (2601); Constipation (3274); Hormonal Imbalance (4495)

Event Date 03/18/2022

Event Type  Injury  

Event Description

Surgery and infection; i had a tubal ligation in 2017.I had talked to the doctor previously about the procedure of having my tubes cut, tied, and cauterized.I've had a lot of pain, heavy bleeding, abdominal swelling, and hormone problems left ovary pain, constipation,and excruciating labor pains since the procedure.I just had an mri done to find the cause of all the problems and discovered that filshie clips were used to block my tubes.One clip is still on my left tube which my new ob removed it during my hysteroscopy on (b)(6) 2022.The mri found the right clip, near my kidney area.Thousands of other women have had the same problems associated with these clips, so it is urgent that we get a class action suit filed so we can afford the surgery to have these clips removed.I've been complaining to my old ob for 5 years of left ovary pains after the clips was placed in.He never mentioned them migrating if he did i wouldn't have got it.He pushed it off never checked the clips after i told him i thought it was the clips he then suggested i get a endometrial ablation to stop the pains.I trusted him so i did this made my pains worse excruciating labor pain every month with cycles.I had to call off from work several times, go to er, urgent cares, try multiple pain meds and because nothing worked.Everytime i went to him after it all failed, he kept asking me to get a hysterectomy to stop it, all i told him 'no'.I want it all reversed.He said it couldn't be reserved and come back when i'm ready for a hysterectomy.My pains got worst last (b)(6) 2022 - (b)(6) 2022.This caused me to now be anemic, i now have endometriosis and now i can't get them reversed.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 14137823
• MDR Text Key: 289699454
• Report Number: MW5109137
• 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: 04/14/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Patient Sequence Number: 1
• Treatment: DOXYCYCLINE; FLAGYL; MAGNESIUM CITRATE ; MELOXICAM; MIRALAX; PERCOCET ; SENNA
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American