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

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Dyspnea (1816); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Thrombus (2101); Cramp(s) (2193); Depression (2361); Sweating (2444); Abdominal Distention (2601); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165)

Event Date 10/15/2017

Event Type  Injury  

Event Description

Right filshie clip broke off tubulization migrated up into my liver.I have my medical records and info to be reached out to.Nothing can be done to remove the clip.I've seen surgeons worse damage will or would have been done removing it then as currently left in liver.I'm left with issues from menstrual cycles, bloating, acid reflux, back pain, sweats, hormone imbalances, pain during activities if i bend forward too fast.Naproxen is my 2-3 times a daily vitamin.The left filshie clip is still in place unbearable.Menstrual cramping, blood clotting, painful at times, i cannot breath.My symptoms of cycle begin two days before bleeding.I do not leave my house the 1st day bleeding.Past two years, weight gain increased, major depression, my perspiration is constant.Mood swings, off balance hormones.No thyroid issues, i was tested for that also.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: 8912296
• MDR Text Key: 155181911
• Report Number: MW5089182
• 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: 08/15/2019

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: 08/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 42 YR
• Patient Weight: 95