FDA Adverse Event Injury Summary report: N

FILSHIE CLIPS

MDR report key: 9682513 · Received February 7, 2020

Report

Report Number
MW5092846
Event Type
Injury
Date Received
February 7, 2020
Date of Event
October 1, 2017
Report Date
February 5, 2020
Manufacturer
COOPER SURGICAL INC. / FEMCARE LTD.
Product Code
KNH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM UNSURE OF THE EXACT DATE THAT MY SYMPTOMS AROSE, BUT I HAD FILSHIE CLIPS USED FOR MY TUBAL LIGATION ON (B)(6) 2015. I WAS NOT GIVEN ANY INFO ABOUT THESE CLIPS, NOR DID I CONSENT TO HAVING THEM. AFTER THIS DATE SOMETIME, I BEGAN TO HAVE UNUSUAL AMOUNT OF BACK PAIN AND UTILIZED THE SERVICE OF MY PHYSICIAN TO TREAT AND DIAGNOSE MY PAIN. THEY TOOK A SERIES OF X-RAYS AND CT SCANS AND I BEGAN TO STUDY THEM. I COULD SEE ON THE FILMS THAT MY FILSHIE CLIPS WERE MIGRATING, AND WITH EACH X-RAY THEY WERE SHOWN IN A DIFFERENT POSITION. FOR TWO YEARS, I HAD EXCRUCIATING BACK PAIN TO THE POINT THAT I COULD NOT EVEN USE THE TOILET DUE TO THE PAIN. MY GYNECOLOGIST DECIDED TO REMOVE THE CLIPS SURGICALLY, BECAUSE HE AND I BOTH CAME TO THE CONCLUSION THAT ONE OF THE FILSHIE CLIPS HAD EMBEDDED INTO MY SACRUM IN THE INSIDE OF MY PELVIS. THE SURGERY HAPPENED IN LATE 2017 I BELIEVE. WHEN HE REMOVED THE CLIPS HE ALSO HAD TO REMOVE A LOT OF ADHESIONS. HAVING TO DEAL WITH THE DRS AND SURGERY WAS TERRIBLE, AND I SUFFERED FOR 2 YEARS BECAUSE OF THESE CLIPS. SHAMEFULLY, BECAUSE OF THE PAIN I WAS IN, I MADE TWO ATTEMPTS OF SUICIDE WHILE IN PAIN. THESE CLIPS ARE DANGEROUS AND SHOULD NOT BE USED. I HAVE A SERIES OF X-RAYS AND CT SCANS THAT I CAN PROVIDE, AS WELL AS RECORDS OF MULTIPLE DR APPTS. I EVEN FILED FOR DISABILITY. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
144069 FILSHIE CLIPS LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE KNH COOPER SURGICAL INC. / FEMCARE LTD.

Patients

Seq Age Sex Outcome Treatment
1 32 YR Hospitalization| R| S KRATOM | PROZAC | VYVANSE | WELLBURTIN