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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPER SURGICAL INC. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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COOPER SURGICAL INC. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Autoimmune Reaction (1733); Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Tingling (2171); Urticaria (2278); Arthralgia (2355); Abdominal Distention (2601)
Date of Event 09/22/2016
Type of Reportable Event Serious Injury
Event or Problem Description
I had filshie clips implanted during my c-section in 2016.The doctor used 4 of them for a tubal ligation.I was not tested for an allergy to titanium, nickel, or silicone.I have a known allergy to nickel.The clips set off an autoimmune response in my body causing ibs, bloating , severe and persistent abdominal pain, hives, dermographia, tingling in my hands and feet, burning in my hands and feet, joint pain, hair loss, acne, hormonal issues, brain fog, and fatigue.
 
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Brand Name
FILSHIE CLIPS
Common Device Name
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
COOPER SURGICAL INC.
MDR Report Key8231588
Report NumberMW5082988
Device Sequence Number17578567
Product Code KNH
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 01/07/2019
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? No
Operator of Device No Information
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/08/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age33 YR
Patient Weight81
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