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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FILSHIE CLIP LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION

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FILSHIE CLIP LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION Back to Search Results
Event Date 05/27/2018
Event Type  Injury  
Event Description

Filshie clip migrated and embedded in colon. Pain began in (b)(6) and i was in and out of hospitals and dr offices with multiple scans of right side. Filshie clip - one has been left inside as the er surgeon only removed the one that broke off.

 
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Brand NameFILSHIE CLIP
Type of DeviceLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
MDR Report Key7637995
Report NumberMW5078072
Device Sequence Number1
Product CodeKNH
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 06/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/25/2018 Patient Sequence Number: 1
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