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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC TRANSVAGINAL MESH

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BOSTON SCIENTIFIC TRANSVAGINAL MESH Back to Search Results
Model Number ADVANTAGE FIT
Device Problem Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 11/12/2015
Event Type  Injury  
Event Description
Had surgery to remove transvaginal mesh, out only pieces of it.
 
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Brand NameTRANSVAGINAL MESH
Type of DeviceTRANSVAGINAL MESH
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key5357945
MDR Text Key35666464
Report NumberMW5059156
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberADVANTAGE FIT
Device Lot NumberM100000197
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/06/2016 Patient Sequence Number: 1
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