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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
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COOPERSURGICAL FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION Back to Search Results
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091)
Date of Event 11/22/2013
Type of Reportable Event Serious Injury
Event or Problem Description
I had a tubal ligation on (b)(6) 2013.I had talked to the doctor previously about the procedure of having my tubes cut, tied, and cauterized.I've had a lot of pain, heavy bleeding, abdominal swelling, and hormone problems associated with ovarian failure since the procedure.I just had an mri done to find the cause of all the problems and discovered that filshie clips were used to block my tubes instead of the procedure i agreed to.Neither clip is still on my tubes.The mri couldn't even find the right clip, so i had an x-ray done to locate the missing clip.It was found down near my bladder area.Thousands of other women have had the same problems associated with these clips, so it is urgent that we get a class action suit filed so we can afford the surgery to have these clips removed.
 
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Brand Name
FILSHIE CLIPS
Common Device Name
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
Manufacturer (Section D)
COOPERSURGICAL
MDR Report Key7352136
Report NumberMW5075936
Device Sequence Number1567120
Product Code KNH
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
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
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/19/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age26 YR
Patient Weight77
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