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 2020-03-03 for FILSHIE CLIPS manufactured by Coopersurgical, Inc..

Event Text Entries

[182512168] My tubal was given in 2015. Successfully as the medical notes state the filshie clips. Last year towards (b)(6) i was having problems with menstrual cramps and pain. My dr was prescribing birth control pills, which did not help. Then she tried nexplanon. I then began heavily bleeding with worsening pain for months non stop. I was having trouble functioning with the pain. I was in the hosp, given ultrasound which did not show any problems besides 2 small cysts on both sides of my uterus. I then was given estrogen pills to see if that would help. I went to an obgyn and was suggested the problem was endometriosis. But the dr informed me he couldn't diagnose that without surgery. So he suggested a partial hysterectomy but informed me that if i had endometriosis that i would eventually need a full hysterectomy if the problems persisted. I elected to do a total hysterectomy due to already being out of work due to medical leave and being a mother of 3 small children under the age of 10. I was having a hard time functioning as it was as a mother, and as a human being and did not want to have to go in surgery more than once. In surgery the dr did not find any endometriosis. The left filshie clip could not be located. The right filshie clip had migrated, was deteriorating and located in my uterus - ovarian ligament. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093495
MDR Report Key9785727
Date Received2020-03-03
Date of Report2020-03-01
Date of Event2019-10-01
Date Added to Maude2020-03-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 Details

Brand NameFILSHIE CLIPS
Generic NameLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Product CodeKNH
Date Received2020-03-03
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2020-03-03

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