MAUDE Adverse Event Report: FILSHIE CLIPS; TUBAL OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Nerve Damage (1979); Pain (1994); Complaint, Ill-Defined (2331); Weight Changes (2607); Heavier Menses (2666); Patient Problem/Medical Problem (2688)

Event Date 09/01/2016

Event Type  Injury  

Event Description

On (b)(6) 2006 i had a tubal ligation done with the fishie clips.Ever since then i suffered with many issues including, extremely heavy periods, painful periods, extreme weight gain, hypothyroidism and now i have learned i am about to enter early menopause.However, the worst is that i recently learned that at least one clip has fallen off and is now lodged in my hip bone region.I am in constant pain and my nerve is severely affected.Often times my leg gives out and i cannot sleep or put pressure on that side at night.Sometimes it radiates all the day into my arm.The worst part is that no one will do anything about it because trying to remove it may be too dangerous.I have spoken with an attorney to see if i could gain any compensation to have surgery to remove the clips since the only doctors who will even attempt to remove them are not covered by insurance.Apparently that cannot happen because it appears all cases get dropped or are lost to the plaintiffs.I am tired of being in extreme pain and having no quality of life at this time.I cry every time i realize how this has messed up my life and want relief that seems will never come.I also have learned there are several studies all around the world that states all the dangers.I truly hope something will be done to prevent the pain and agony i live with everyday from happening to other women.

• Brand Name: FILSHIE CLIPS
• Type of Device: TUBAL OCCLUDER
• MDR Report Key: 5973272
• MDR Text Key: 55608925
• Report Number: MW5064998
• Device Sequence Number: 1
• Product Code: KNH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/21/2016

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: 09/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 120