FILSHIE CLIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-26 for FILSHIE CLIPS manufactured by Cooper Surgical.

Event Text Entries

[50415112] (b)(4) this started with stabbing abdominal pains, memory fog, dizzy spells, and spinal pain. I had to stop working. I thought everything was just my back. Then i had bowel bleeding. My doctor just treated me for hemorrhoids. Bled more but i ignored it. Kept complaining about stabbing pains. Obgyn blamed it on ovarian cysts and refused to look at the clips. My mental health got worse. I had hot flashes and cold sweats. My body hurt all over. I found out i had hypothyroidism. I finally decided to take my life back. I saw my doc and asked for referrals. I had a ct scan to find out where the clips were. The report said that 4 clips were present. I didn't think it looked right. Then i saw an allergist. Found out i'm allergic to nickel. According to cooper surgical there is nickel in the silicone. After finding all this out; i went to see my obgyns again. I always felt like someone was taking a dagger and stabbing me. I also have had bowel problems. I begged my obgyn for a reversal or tubes out. I wanted them out of my body. I knew they were the problem after all my appointments and research. They agreed to take my tubes out. Surgery was on (b)(6) 2016. They found 2 clips on one tube. The other tube had nothing on it. It looked like it had been cut and burned. They found the 3rd clip buried deep in my pelvis. Fourth (4th) clip was no where to be found. So i was ordered an xray. They instantly had a tech look at it and send it straight to my doc. The clip is in/near my bowel. If i would of ever been told that the filshie clips could fall off and go where they want; i would of never gotten them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5063641
MDR Report Key5821971
Date Received2016-07-26
Date of Report2016-02-16
Date of Event2016-07-21
Date Added to Maude2016-07-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameFILSHIE CLIPS
Product CodeKNH
Date Received2016-07-26
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerCOOPER SURGICAL

Device Sequence Number: 1

Brand NameFILSHIE CLIPS
Product CodeHGB
Date Received2016-07-26
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOPER SURGICAL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit 2016-07-26

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