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U.S. Department of Health and Human Services

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

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C. R. BARD, INC. MARLEX MESH MESH, SURGICAL POLYMERIC Back to Search Results
Device Problem Protective Measures Problem (3015)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/13/2018
Event Type  Injury  
Event Description
Mom had a hernia surgery and the mesh became ¿undone¿ so an additional surgery was needed. I do not have the correct dates of these surgeries. Recently in (b)(6) 2018, mom had an ileus of the small intestines in which the surgeon thought the small intestine attached to the mesh. One brand name of the mesh was marlex and the other was teflon. Surgeries and stays in assistant living / skill care for a month after staying in hosp for two months. Surgical mesh for hernias.
 
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Brand NameMARLEX MESH
Type of DeviceMESH, SURGICAL POLYMERIC
Manufacturer (Section D)
C. R. BARD, INC.
MDR Report Key7947040
MDR Text Key123494161
Report NumberMW5080420
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 Family Member or Friend
Type of Report Initial
Report Date 10/05/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/05/2018
Is this an Adverse Event Report? No
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: 10/05/2018 Patient Sequence Number: 1
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