FILSHIE CLIP COOPER SURGICAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for FILSHIE CLIP COOPER SURGICAL manufactured by Cooper Surgical.

Event Text Entries

[41207753] The doctor sent me to the hospital (b)(6) 2014, as he said my white blood cell count was high and with the extreme stomach pain, nausea and fever, he thought my appendix was going to burst. All three of my filshie clips had come off the isthmus and migrated to the complete opposite side of my body in which they were placed during my surgery on (b)(6) 2010. I endured extreme pain, nausea, stomach aches and cramps. I suffer extreme fatigue, headaches and my skin has broken out into rashes with yellow puss coming out 3 months after my surgery, but no doctor could figure out this chronic bacterial infection i had. On (b)(6) 2015, i ended up back in the hospital, this time with extreme pain in my right lung, my ribs burn, my stomach aches, i had an xray and, once again, two of my filshie clips are now on the opposite side of my body and one is under my right rib cage. The second time in the hospital, and exactly where my pain is, they find these filshie clips. The mfr of these filshie clips claim to fame is that they are reversible with a 90% success rate. How can they, when mine have fell off and migrated 4 years after surgery that i know of and could have been sooner. During the time frames between hospital visits, ultrasounds, mri's and ct scans to figure out this bacterial infection, i came to find that these clips are made from a titanium nickel which i am allergic to and never was brought to my attention. They say the clip and silicone rubber is an implantable grade but i'm pretty sure it's not. There are dozens of (b)(6) pages with thousands of women going through many painful side effects. So, either all the doctors do not know how to put on these clips, or the mfr has a faulty applicator and filshie clips, because these clips are not staying on. There is also no warning that these clips could fall off when you give consent for this surgery with this filshie clip other than surgical complications. Trust me, if someone said that there is a good change these clips would fall off and migrate through your body, i would have said no way in hell. This product is exactly like essure, another multi-million dollar company making money and not giving a second thought to the many women who suffer form the products that should never been approved in the first place. I have 5 xrays over 4 years that show these clips in different spots in my body each time. They have completely ruined my tubes, my life, and my health.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5061217
MDR Report Key5522249
Date Received2016-03-21
Date of Report2016-03-21
Date of Event2010-06-08
Date Added to Maude2016-03-24
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 Report0

Device Sequence Number: 0

Brand NameFILSHIE CLIP
Generic NameFILSHIE CLIP
Product CodeKNH
Date Received2016-03-21
Model NumberCOOPER SURGICAL
Lot Number23903 AND 23748
Device Expiration Date2013-11-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerCOOPER SURGICAL

Device Sequence Number: 1

Brand NameFILSHIE CLIP
Generic NameFILSHIE CLIP
Product CodeHGB
Date Received2016-03-21
Model NumberCOOPER SURGICAL
Lot Number23903 AND 23748
Device Expiration Date2013-11-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOPER SURGICAL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2016-03-21

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