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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 Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Visual Impairment (2138); Anxiety (2328); Depression (2361); Weight Changes (2607); Swelling/ Edema (4577)
Event Date 04/21/2011
Event Type  Injury  
Event Description
Sharp stabbing pain in ovaries, after tuba ligation with clips, severe bleeding, irregular periods, extremely sore breast, migraines , weight gain and not able to lose weight, depression, severe anxiety, brittle hair and nails, hair loss.Eczema, unexplained rashes and itching on skin, edema, thyroid disease, gastrointestinal issues, vision changes.Just over all my health has slowly gone down hill since my tuba ligation and no doctor has said it is related.I've had mri, x-ray, ct scans , ultrasound, blood tests, and nothing is claimed to be related but yet all of these health issues started after i had these clips put in my body.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 Key12616539
MDR Text Key276343278
Report NumberMW5104543
Device Sequence Number1
Product Code KNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age28 YR
Patient Weight122
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