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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMCARE LIMITED FILSHIE CLIP APPLICATOR, 7MM DI (CSI); DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
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FEMCARE LIMITED FILSHIE CLIP APPLICATOR, 7MM DI (CSI); DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE Back to Search Results
Model Number AVM-863
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
Filshie clips were used during procedure.On placement of first filshie clip it was noticied that the device was loose at the tip.A small piece of metal was noticied in abdomen next to where first clip placed.Metal piece was retrieved and abdomen inspected for a remaining foreign metal pieces.Nothing else was noted.Filshie clip applier was inspected for missing piece but nothing else noticed.Clip applier was sequestered along with metal piece retrieved.New filshie clip applier was used and procedure completed.
 
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Brand Name
FILSHIE CLIP APPLICATOR, 7MM DI (CSI)
Type of Device
DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Manufacturer (Section D)
FEMCARE LIMITED
7043 south 300 west
midvale UT 84047
MDR Report Key11699976
MDR Text Key246482615
Report Number11699976
Device Sequence Number1
Product Code KNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/13/2021,04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAVM-863
Device Catalogue NumberAVM-863
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2021
Date Report to Manufacturer04/21/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age12410 DA
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