FILSHIE CLIPS TUBAL LIGATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for FILSHIE CLIPS TUBAL LIGATION manufactured by Femcare Ltd..

Event Text Entries

[176038065] I had my tubes the (filshie clamps) in 2011, after that i started to have heavy bleeding, bad menstrual period, blood clots, ovarian cysts so on; (b)(6) 2019 i had a hysterectomy fallopian tubes removed and uterus not my ovaries, but (b)(6) 2020 a month later, i went to the bathroom and a clamp came out, weird. I just had a hysterectomy and my fallopian tubes were removed. I went back to my dr and he said to me he did see it in my stomach but left it because it was a complicated surgery nd he did not want to mess with me anymore also because i was bleeding a lot. Please help me out. I don't know what to do, i have the filshie clamp with me, i don't know if it was. Medical malpractice but i have heard many stories of other woman having the same issue with the clamps after tubal ligation. Thanks. Fda safety report id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092363
MDR Report Key9610817
Date Received2020-01-17
Date of Report2020-01-15
Date of Event2019-12-10
Date Added to Maude2020-01-21
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 TUBAL LIGATION
Generic NameLAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION
Product CodeKNH
Date Received2020-01-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFEMCARE LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.