MAUDE Adverse Event Report: MESH

Device Problem Malposition of Device (2616)

Patient Problems Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Fluid Discharge (2686)

Event Date 01/01/2008

Event Type  Injury  

Event Description

Reporter had gall bladder surgery in 2008.Surgeons found abdominal hernia and implanted mesh.In 2009, the mesh malpositioned, blood and fluid accumulated near the mesh and had to drain them.It happened 4 times in the same year.In 2010, mesh malpositioned and stomach hanging out.She also had pneumonia.Doctors did the barium test and ct scan.Pt had the stomach repair surgery and was on ventilator in icu for 14 days.In (b)(6) 2011, the pt had fluid accumulation and had to drain them.In 2011, pt suffered from pain and infection.Intestines were hanging out and abdominal wall was loosed.Pt had mesh repair surgery in (b)(6) 2011.Pt still has pain.She can feel the knot in her stomach area.One side of her abdomen is bigger than the other.Mesh is still implanted.Pt had different opinions from three different surgeons concerning the mesh.Pt is confused and needs help.

• Brand Name: MESH
• Type of Device: MESH
• MDR Report Key: 5150190
• MDR Text Key: 28342468
• Report Number: MW5056971
• 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: Patient
• Type of Report: Initial
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 90