MAUDE Adverse Event Report: SURGICAL MESH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330)

Event Date 01/16/2015

Event Type  Injury  

Event Description

In 2006, i had surgery to correct an incisional hernia, dr.(b)(6) was the surgeon and he used mesh to repair the hernia.I do not know the manufacturer of the mesh.Sometime in late 2013 or 2014, i began noticing a great amount of discomfort in the area of the surgery.I first though it was either my button or snap on my pants irritating the area.Then i thought maybe it was that i was eating.Then i wondered if the hernia could be back.Finally i consulted first my pcp, who examined me and could find no evidence of another hernia.Then i went to another dr who said it was the mesh being irritated that was causing my problems.His suggestion was to wear bigger pants.Then i went back to dr.(b)(6) and he said basically the same thing.The mesh sometimes gets irritated, but it should go away in a couple of months.He also said if he took the mesh out, my hernia would return.It's been more than a year, and sometimes the pain in my abdominal area is so intense, it is difficult to conduct my daily activities.I wish i had known this before the surgery.

• Brand Name: SURGICAL MESH
• Type of Device: SURGICAL MESH
• MDR Report Key: 5401872
• MDR Text Key: 37305706
• Report Number: MW5059810
• Device Sequence Number: 1
• Product Code: FTM
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 75