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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL MESH

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SURGICAL MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 08/23/2017
Event Type  Death  
Event Description
Bled to death during hip arthroplasty, previously had pop mesh attached to blood vessels. Fda safety report id# (b)(4).
 
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Brand NameSURGICAL MESH
Type of DeviceSURGICAL MESH
MDR Report Key8807916
MDR Text Key151611920
Report NumberMW5088249
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 07/19/2019 Patient Sequence Number: 1
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