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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hair Loss (1877); Headache (1880); Nausea (1970); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Date 11/12/2019

Event Type  Injury  

Event Description

I had gotten filshie clips in the year 2013 and i noticed i started having heavier periods, my hair started to thin, i gained weight and was in severe pain when i ovulated and when i had my period.When i say severe i mean my back would ache, my legs would have a shooting pain from my hips to my knees and migraines also had nausea and all of this happened before my periods.Went to the doctor stated this was a normal side effect but something to me was not right, kept on being in pain and taking ofc meds as the doctor suggested, anyways fast forward to 2019 i found a new gyn doctor, he stated to me having all those symptoms were not normal, he suggested to remove the filshie clips.As more studies happened he found out my fallopian tubes were damaged and the clips had migrated to my ovaries.On (b)(6) 2019 i underwent surgery to have my fallopian tubes removed and a uterine ablation done.I know having my tubes tied was my decision and again the doctor who had spoken to me stated it was only going to be tired not clamped and when i called the hospital they had told me it was filshie clips that were placed and if i ever wanted i could easily have them removed.I am not the only person that has gone threw this situation there are millions of women that the filshie clips has messed them up and no one is doing anything about this.My chances of every having another child are gone.I have gone into severe depression and hurt not mention i had to have a long painful recovery.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED LTD.
• MDR Report Key: 9511083
• MDR Text Key: 172605684
• Report Number: MW5091835
• 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: 12/19/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 104