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U.S. Department of Health and Human Services

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

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FEMCARE LTD. FILSHIE CLIPS LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Inadequate Pain Relief (2388)
Event Date 05/01/2019
Event Type  Injury  
Event Description
My doctor recommended filshie clips for tubal ligation. I asked to have my tubes tied but she pushed the clips. Almost immediately after getting them, i started having pain. I went back to the dr. And she said it wasn't the clips. I went to 5 doctors in a year. They all said "it was ibs" or "just my period". I knew it was from the filshie clips but no one would listen. They prescribed me medications i didn't need and ibuprofen that didn't help. Finally a dr. Listened and found that both the clips had migrated into my uterus. I asked to have the clips and the dr. Refused to give them to me. I can't file a lawsuit until you remove them from the market. I'm not alone. Thousands of women have gone through the same thing or worse. I still experience excruciating pain a year after removal from scarring. Do the right thing for us who are still suffering. Never tested for ibs. Avalon medical corporation. Fda safety report id# (b)(4).
 
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Brand NameFILSHIE CLIPS
Type of DeviceLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE LTD.
MDR Report Key12985187
MDR Text Key282218147
Report NumberMW5105977
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 12/08/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/10/2021 Patient Sequence Number: 1
Treatment
MULTI VITAMIN
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