MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Irritability (2421); Weight Changes (2607); Heavier Menses (2666)

Event Date 02/01/2017

Event Type  Injury  

Event Description

(b)(4).First of all, it wouldn't let me put a different date.The symptoms started about 3 months after the surgery (when i started my menstrual cycle again).I would feel a tightness on the right side and would be in a ton of pain.I developed pms which i had never experienced before.My periods were lasting anywhere from 5-7 days with the majority of those being very heavy days.A normal period for me is an average of 3 days with 1 semi-heavy day.I was having to sleep with a pad and tampon and would wake up in the night to change them out.I stayed tired and it was very difficult to lose any weight but easy to gain it, i gained about (b)(6) pounds with these clips in.I was very moody and would get mad at the smallest thing.My husband said i had become somewhat of a different person.I don't do well with foreign objects in my body and always have to have them removed.I ended up going back to my previous obgyn and he recommended i have the clips and my tubes removed.I had this surgery in (b)(6) 2016.It turns out my right tube and clip were covered in scar tissue and the pain i was feeling was coming from the pulling of the clip.I asked to keep the clips and my dr.Provided me with pictures of the procedure.Since the removal of these clips my life has gotten for the most part back to normal.The pms has gone away as well as the moodiness and irritability.My period has gone back to my normal cycle and i have not had and overly heavy days.I have also managed to lose almost (b)(6) pounds as well.You can not tell me that these clips did not cause some if not all of the adverse symptoms i had.These clips have no place in the female body and should be taken off the medical shelf as an option.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6353308
• MDR Text Key: 75476452
• Report Number: MW5068071
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: Not provided
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32.000 YR