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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC/FEMCARE LTD. FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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COOPERSURGICAL, INC/FEMCARE LTD. FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Pain (1994); Urticaria (2278); Weight Changes (2607)
Event Date 01/25/2015
Event Type  Injury  
Event Description
Right after surgery for tubes being tied with filshie clips.I had an ongoing infection that lasted months after the tubal.Stabbings pains, ovarian cyst that i never had prior to getting tubes tied, weight gain, hives etc.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)
COOPERSURGICAL, INC/FEMCARE LTD.
MDR Report Key8866365
MDR Text Key153641618
Report NumberMW5088837
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 08/04/2019
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) Hospitalization;
Patient Age21 YR
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