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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMCARE LTD. FILSHIE CLIP LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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FEMCARE LTD. FILSHIE CLIP LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 07/27/2021
Event Type  Injury  
Event Description
Fertility issues; filshie clips were place (b)(6) 2017 and was notified after unrelated ct that the left clip has dislodged and migrated into the right pelvis. Previous ct done on (b)(6) 2019 showed now issues with clips. Fda safety report id # (b)(4).
 
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Brand NameFILSHIE CLIP
Type of DeviceLAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
FEMCARE LTD.
MDR Report Key12293827
MDR Text Key265971346
Report NumberMW5103077
Device Sequence Number1
Product Code KNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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: 08/06/2021 Patient Sequence Number: 1
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