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UNKNOWN VAGINAL MESH Back to Search Results
Device Problems Material Erosion (1214); Device Issue (2379)
Patient Problems Erosion (1750); Inflammation (1932); Pain (1994)
Event Date 12/14/2016
Event Type  Injury  
Event Description
Patient complained of difficulty urinating secondary to eroded mesh. A small piece of mesh was excised from the urethra.
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Type of DeviceVAGINAL MESH
Manufacturer (Section D)
MDR Report Key5427421
MDR Text Key38081623
Report Number5427421
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 01/26/2016,12/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2016
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 FDA12/26/2016
Distributor Facility Aware Date01/14/2016
Device Age4 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: 02/10/2016 Patient Sequence Number: 1