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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 Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Itching Sensation (1943); Memory Loss/Impairment (1958); Rash (2033); Thrombus (2101); Cramp(s) (2193); Depression (2361); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)
Event Date 11/17/2018
Event Type  Injury  
Event Description
Had filshie clips inserted during a tubal ligation.I have had horrible medical issues including extreme exhaustion, itchy/rash skin, acne all over my body but worse in areas on face related to hormones, extreme mood swings, rage and depression, loss of joy in life, weight gain and bloating, hair loss, hormonal imbalance, fogginess of brain and forgetfulness, lack of motivation, loss of sex drive, severe cramping during menstrual cycle, large blood clots during cycle, very heavy cycles.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 Key9328353
MDR Text Key166790536
Report NumberMW5091094
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 11/12/2019
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 Received11/14/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age34 YR
Patient Weight70
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