MAUDE Adverse Event Report: MESH/ANCHORS

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Fatigue (1849); Nausea (1970); Vomiting (2144); Weakness (2145); Weight Changes (2607); Constipation (3274)

Event Type  Injury  

Event Description

In april 2000, i had abdominal wall incisional hernia repair, where mesh along with anchors were placed.I also had abdominoplasty preformed.As soon as my six week follow-up, i complained of abdominal pain.I could feel tension in my abdomen and little areas of pocketed pain.The doctor explained i was forming scar tissue over the anchors and that with time, the pain would go away.It was not.I have had years of abdominal wall pain, difficulty lifting, bending and severe pain while sick with a cough.In (b)(6) 2015, i underwent abdominal surgery for abdominal pain and weight gain.The surgeon did nearly five hours of small bowel surgery with an excessive amount of lysis of adhesions.Today, i am worse than before surgery.I have nausea, vomiting, cycles of constipation and explosive diarrhea.I am weak, tired, have a great deal of abdominal pain.I seem to learn a new physical limitation daily.I am convinced the mesh/anchors that were placed in my abdomen was the beginning of my slow decline.

• Brand Name: MESH/ANCHORS
• Type of Device: MESH/ANCHORS
• MDR Report Key: 4815031
• MDR Text Key: 5923569
• Report Number: MW5042915
• Device Sequence Number: 2
• Product Code: OTP
• 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: 05/26/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Weight: 75