MAUDE Adverse Event Report: COVIDIEN PARIETEX; SURGICAL MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Vomiting (2144); Abdominal Cramps (2543); Constipation (3274)

Event Date 10/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 i had a ventral hernia repaired using parietex mesh using secure-strap.Initially, i felt soreness, as expected from the surgery.Approximately, 5-6 months after the surgery i started feeling the same signs and symptoms as i did with the ventral hernia.Two and a half years have passed and i am still having nausea, vomiting, constipation and severe abdominal cramps.

• Brand Name: PARIETEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6215325
• MDR Text Key: 63724945
• Report Number: MW5066986
• 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: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: COLACE; OTC MEDS: MULTIVITAMIN; PEPCID; PEPTO BISMOL; RX MEDS: PARIETEX MESH; SIMETHACONE; VITAMIN B12; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 67