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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Sepsis (2067); Tissue Damage (2104)
Event Date 09/20/2016
Event Type  Injury  
Event Description
I had filshie clips put in a week after (b)(6) 2015 and had one of the clips shred my right fallopian tube and attach itself to my bowel wall; i was told if i would have moved just right i would have ripped a hole in my wall and gone septic.I had my ob/gyn removed the clips.Later in 2017 i had a hysterectomy due to continuous pain from being torn to shreds.Fda safety report id: (b)(4).
 
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Brand Name
FILSHIE CLIPS
Type of Device
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE LTD.
MDR Report Key9610794
MDR Text Key176035571
Report NumberMW5092362
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 No Information
Was Device Available for Evaluation? No
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) Hospitalization; Required Intervention;
Patient Age23 YR
Patient Weight59
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