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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMCARE LTD FILSHIE; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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FEMCARE LTD FILSHIE; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Pain (1994); Blood Loss (2597); Heavier Menses (2666)
Event Date 06/14/2013
Event Type  Injury  
Event Description
I had my 3rd child via cesarean section in 2008 and they used filshie clips to block my tubes.Since then i've had heavy and painful periods.They got so bad i became severely anemic and needed a blood transfusion in 2016 but i opted out and decided to take an iron supplement with vitamin c for better absorption.Then i was placed on camrese birth control pill so i would have my period 4 times a year and not loose so much blood and be in pain.I have doing research and i'm pretty sure i have ptls.I hope to get them removed.Fda safety report id# (b)(4).
 
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Brand Name
FILSHIE
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE LTD
MDR Report Key9128716
MDR Text Key160420502
Report NumberMW5090065
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 09/17/2019
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/27/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
CAMRESE; IRON ; VIT C; ZOLOFT
Patient Outcome(s) Disability;
Patient Age21 YR
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