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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 Patient-Device Incompatibility (2682)
Patient Problems Cyst(s) (1800); Pain (1994); Blood Loss (2597)
Event Date 11/25/2015
Event Type  Injury  
Event Description
After my last baby my obgyn told me that i should not have any more babies so i told her to sterilize me.She didn't explain what she was going to do or put into me i found out after my surgery about a couple of days after my surgery i was bleeding heavily and was in so much pain.She said it was normal after having filshie clips put in i said ok.Well about three months later i was still in pain.She turned her head and thought i was crazy.I have had nothing but pain, an ovary cyst, a lot of ovary cyst, i have nothing but pain, i was just at the "we" with pain so bad i doubled over an found out i have a cyst about 2cm big.Sex is painful all the time and i have tried to get a doctor to take them out an nobody will unless i have (b)(6) dollar to have them removed.I want a normal life again where i was not in pain i have been in pain since 2015.Medical problems.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 Key8866410
MDR Text Key153645602
Report NumberMW5088840
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 08/03/2019
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 Received08/05/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28 YR
Patient Weight62
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