MAUDE Adverse Event Report: COVIDIEN HERNIA MESH PARIETEX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Injury (2348)

Event Date 06/01/2016

Event Type  Injury  

Event Description

I had another hernia surgery using the parietex mesh and after a while holes in my stomach started developing.They drain constantly and i have fevers all the time from them.When i went back to my surgeon he was absolutely nasty to me, defensive stating it wasn't his fault, since then i'm unable to find a surgeon to repair it.

• Brand Name: HERNIA MESH PARIETEX
• Type of Device: HERNIA MESH PARIETEX
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6940220
• MDR Text Key: 89255768
• Report Number: MW5072676
• 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: Patient
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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; Disability
• Patient Weight: 55