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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMCARE LTD. FILSHIE CLIP ; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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FEMCARE LTD. FILSHIE CLIP ; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Scarring (2061)
Event Date 11/15/2014
Event Type  Injury  
Event Description
I had a tubal ligation in 2012, wasn't told they were putting in filshie clips.Started having abdominal pain and had many er visits due to pain in (b)(6) 2015 i had laparoscopy surgery to remove clips due to complications and migration.Only one clip was found at this time, which was embedded in the side of my uterus.The other clip wasn't found at this time.Was still having severe abdominal pain, in (b)(6) 2016 i had my 3rd surgery to locate and remove the clip, it was found embedded begging my colon.I have scarring due to all the surgeries and experience abnormal and painful menstruation now.I was a healthy woman with no female issues until i had my tubal ligation.I am now trying to get a tubal reversal to fix all the damage done by the filshie clips.Fda safety report id # (b)(4).
 
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Brand Name
FILSHIE CLIP
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE LTD.
MDR Report Key9496147
MDR Text Key172230808
Report NumberMW5091764
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 12/16/2019
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/18/2019
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
Patient Weight46
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