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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMCARE LTD. FILSHIE CLIPS TUBAL LIGATION; LAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION

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FEMCARE LTD. FILSHIE CLIPS TUBAL LIGATION; LAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Expulsion (2933)
Patient Problems Cyst(s) (1800); Menstrual Irregularities (1959); Thrombus (2101); Heavier Menses (2666)
Event Date 12/10/2019
Event Type  Injury  
Event Description
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).
 
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Brand Name
FILSHIE CLIPS TUBAL LIGATION
Type of Device
LAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION
Manufacturer (Section D)
FEMCARE LTD.
MDR Report Key9610817
MDR Text Key176038065
Report NumberMW5092363
Device Sequence Number1
Product Code KNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
Patient Weight86
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