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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SURGIPRO MESH

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COVIDIEN SURGIPRO MESH Back to Search Results
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Incontinence (1928); Pain (1994); Discomfort (2330); Impaired Healing (2378)
Event Date 10/24/2014
Event Type  Injury  
Event Description
The caller reported that she was implanted with a surgipro mesh for a hernia repair on (b)(6) 2014. Since implantation the wound did not heal. She is recently experiencing protrusion of fibers from the mesh in different areas of her abdomen causing pain, discomfort, and incontinence. She contacted her doctor and was told the only thing he can do is to remove the mesh. The doctor also advised that the operation will be too much of a risk because of her age and numerous surgeries in the past.
 
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Brand NameSURGIPRO MESH
Type of DeviceMESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key5947072
MDR Text Key54652744
Report NumberMW5064709
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

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