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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. ABDOMINAL MESH-BARD MESH, SURGICAL, POLYMERIC

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C. R. BARD, INC. ABDOMINAL MESH-BARD MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Obstruction/Occlusion (2422)
Event Date 11/17/2018
Event Type  Injury  
Event Description
Mesh was tangled with intestines and caused a blockage. Needed emergency surgery to untangle. Lost part of my colon and then got infection. Almost died.
 
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Brand NameABDOMINAL MESH-BARD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
C. R. BARD, INC.
MDR Report Key8273977
MDR Text Key134096037
Report NumberMW5083313
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 Patient
Type of Report Initial
Report Date 01/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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: 01/23/2019 Patient Sequence Number: 1
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