MAUDE Adverse Event Report: HERNIA SYNTHETIC MESH; MESH, SURGICAL, POLYMERIC

Device Problems Degraded (1153); Folded (2630)

Patient Problems Adhesion(s) (1695); Pain (1994); Discomfort (2330); No Code Available (3191); Constipation (3274)

Event Date 08/25/2015

Event Type  Injury  

Event Description

Synthetic mesh implant in 2005, constant pain and discomfort, lived with it, 2012 digestive issues added, multiple er visits, constipation, intestines blocked, 2015 no bowel movement, rushed to er toxins backing up, ng tube attempted, rushed to "exploratory" surgery, incision from belly button down, mesh immediately visible and degradation seen, portions folded over looped in small intestine, partial mesh and dead small intestine, unable to remove remaining damaged mesh due to adhesions.In 2017 complications are back.Getting run around along with battery of test to exclude any other possible issue.Not wanting to acknowledge remaining mesh seems to be causing blockage again.

• Brand Name: HERNIA SYNTHETIC MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 7553390
• MDR Text Key: 109762958
• Report Number: MW5077535
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 64