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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Hemorrhage/Bleeding (1888); Pain (1994)
Date of Event 08/03/2012
Type of Reportable Event Serious Injury
Event or Problem Description
I had gotten the filshie clamps in (b)(6) 2012.Started having problems right after, told dr, he said give it time.So i did and i was still in a lot of pain and was bleeding for more than a month straight.I had a hysterectomy in (b)(6) of 2016.I am not on medication due to having a hysterectomy.
 
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Brand Name
FILSHIE CLIPS
Common Device Name
LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
MDR Report Key7273445
Report NumberMW5075278
Device Sequence Number1903930
Product Code KNH
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2012
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 02/12/2018
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 Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/14/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Weight57
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