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 2013-11-08 for FILSHIE CLIPS manufactured by Cooper Clips.

Event Text Entries

[16801966] In 2008 i had a tubal ligation done with filshie clips, i had severe bloating. I had one period and got pregnant the next month. I lost this pregnancy at 20 weeks. I had a hsg done and they told me my tubes were blocked. I then had severe bloating and pain in my abdomen one week before every period. My periods became 7-10 day events. So much blood and huge clots. I became anemic because of how heavy my periods were. My periods before getting the filshie clips were nothing like what i was experiencing. My doctor told me that it wasn't from my tubal and offered me birth control pills, ablation or as a final resort a hysterectomy to control my bleeding. I had no problems before my tubal. I went on iron pills and guess what i got pregnant again. This time i had a healthy baby boy and during my c-section the doctor looked at my tubes. In my op report it states my left clip has slipped or a new opening grew over the clip. My right clip is firmly on for now but it appears my left one has slipped. Having the filshie clips in my body has changed my periods so much it has affected my life, i was not warned this could happen to me.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5032730
MDR Report Key3469624
Date Received2013-11-08
Date of Report2013-11-07
Date of Event2008-04-14
Date Added to Maude2013-11-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFILSHIE CLIPS
Generic NameFILSHIE CLIPS
Product CodeHGB
Date Received2013-11-08
Device Sequence No1
Device Event Key0
ManufacturerCOOPER CLIPS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2013-11-08

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