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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAGINAL MESH

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VAGINAL MESH Back to Search Results
Device Problems Explanted (1217); Leak/Splash (1354); Malfunction (2409)
Patient Problem Pain (1994)
Event Date 08/04/2016
Event Type  Injury  
Event Description
Patient states she has had pain since the mesh was implanted in 2013. She still has some leakage and states she has pain with intercourse that is worsening.
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Brand NameUnknown Brand Name
Type of DeviceVAGINAL MESH
MDR Report Key5882759
MDR Text Key52410515
Report Number5882759
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/08/2016
Distributor Facility Aware Date08/04/2016
Device Age3 YR
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/16/2016 Patient Sequence Number: 1