MAUDE Adverse Event Report: COVIDIEN SURGIPRO MESH

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.

• Brand Name: SURGIPRO MESH
• Type of Device: MESH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5947072
• MDR Text Key: 54652744
• Report Number: MW5064709
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 118