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

Device Problem Migration (4003)

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Anxiety (2328); Depression (2361); Weight Changes (2607); Heavier Menses (2666)

Event Date 06/26/2006

Event Type  Injury  

Event Description

After i had my pet procedure on (b)(6) 2006, i didn't feel the best as i just had my baby that morning.I was discharged from the hospital and started swelling in my whole body.I couldn't lay down without feeling like i would drown.My asthma got worse and i started bleeding more than usual.I was admitted back in the hospital where i had to take diuretics, was treated for high blood pressure due to the edema and have breathing treatments.I was never alerted to what really was the problem as i was also not aware what form of tubal ligation i was receiving until years later.I did a consent, but i never said that these clips were going to be put in my body.After i finally was able to be released from the hospital for the second time, i started gaining weight for no reason as i didn't want anything different and was no less active.It was actually the opposite, i now had a new baby and was more active.So the excessive weight gain was not my cause.I started having excessive bleeding during my monthly cycle and became more anemic than i ever was in the past due to the bleeding.I had to start taking meds to lessen the bleeding.I started going to the hospital for abdominal pain especially on my left side with no seen cause.Only thing that was seen on the ultrasounds i received was that my right clip had fallen off and was just floating in my left pelvis.Throughout the years, i kept going back to the hospital for the same pain, but it was never a solution just told i was ok.I feel excruciating pain so bad that it drops me to my knees, even when outside and it's very humiliating for people to see.I have depression more these days and i know clips are the problem as i was better prior to the clips.I have headaches all the time but can't take really anything for it besides ibuprofen because i'm allergic to other pain meds.I still swell in my hands and feet.I'm weak and tired all the time and my hair is falling out and having a hard time growing back.My skin is worse and drier than usual and i have more cystic acne as well.My sexual life has been affected tremendously as it hurts and my abdomen starts to be in a lot of pain, which radiates down through my vagina making intercourse very difficult.Overall, i feel awful, sad and depressed.During my depressed feeling and anxiety heightened, it's been very difficult to get employment.I have tried medications, with no help, counseling, no help and have tried to get on disability, which i was denied due to my age.I'm not trying to blame everything on these clips, but i do know that i felt fine and healthier before these were put in my body.I do want them out, but only them, not the ovaries and whatever people get out to try to get added relief.I have kids and it's very hard to be there for them when i'm fighting for my own problem with this.I need relief.Have some hospital records of my ultrasounds, but i don't have the other visits for the other problems that exist readily available.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: 8768413
• MDR Text Key: 150606234
• Report Number: MW5087922
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2019
• 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
• Patient Age: 42 YR
• Patient Weight: 134