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

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Urinary Tract Infection (2120); Depression (2361)

Event Date 10/18/2008

Event Type  Injury  

Event Description

During c section of last baby i requested tubal litigation.I assumed the doctor would cut and burn tubes, instead the doctor put in 2 filshie clips.Immediately after having my last child i had pain.I assumed from the c-section.Over the next 10 years, i had constant problems! pain, pain during sex, pain during ovulation was horrible.Longer heavier periods.I had never had any problems with any of these.Then came infections, constant uti, yeast, bv.I could never get rid of it.I missed days of work from the pain, was becoming depressed thinking this is horrible, my ob who put clips in told me clips had nothing to do with it.I finally went to a chiropractor, at this point i was in constant pain in pelvic and lower back.Chiropractor took x ray and found both clips were not where they should be! explaining the pains i was having.The chiropractor said clips had to come out.I went to 4 different obs until i found one who would listen to me.This ob does not use filshie clips or hulka clips, for this reason! this clips eventually fall off the tubes once they kill the tube tissue and then become a "where will i go now" piece of mental.This ob took pictures during my procedure.I couldn't believe the destruction these clips caused to my body! i couldn¿t believe these clips did this.I had adhesions, cut up internal damage all from the clips just wondering around my body trying to find a place to settle.I ended up having to have a hysterectomy because of all the damage these clips caused.Thank god my ob was able to get both clips out! and now, i'm perfect! no pain.No infections.I'm a new person.Please, please, please do something about these horrible devices! they should not be placed in woman's body! ever! dates: (b)(6) 2008 c section, tubal, clips put in without me knowing next 10 years constant problems.(b)(6) 2018 clips removed, hysterectomy not one problem since! i am a healthy non-smoker who works 40-50 hours per week.I've never had anything medical except ob related.Please feel free to contact me.(b)(6).Filshie clips dislodged from tubes.X-ray showed clips in lower pelvis not near tubes.Cat scan stated one clip was lodged in posterior cul-de-sac behind uterus.Second clip in tissue just in front of spin (causing pelvis and back pain).(b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL, OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 8767893
• MDR Text Key: 150529382
• Report Number: MW5087908
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 28 YR
• Patient Weight: 84