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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC SOLYX MESH

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BOSTON SCIENTIFIC SOLYX MESH Back to Search Results
Lot Number 20883194
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 12/18/2017
Event Type  Injury  
Event Description
Solyx mesh implanted (b)(6) 2017 expelled by patient on (b)(6) 2017.
 
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Brand NameSOLYX MESH
Type of DeviceSOLYX MESH
Manufacturer (Section D)
BOSTON SCIENTIFIC
gouverneur NY 13642
MDR Report Key7142188
MDR Text Key95735647
Report NumberMW5074190
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number20883194
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 12/21/2017 Patient Sequence Number: 1
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