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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN VAGINAL MESH

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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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Brand NameVAGINAL MESH
Type of DeviceVAGINAL MESH
Manufacturer (Section D)
UNKNOWN
MDR Report Key5427421
MDR Text Key38081623
Report Number5427421
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)
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 HEALTH PROFESSIONAL
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
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