MAUDE Adverse Event Report: COVIDIEN PARIETEX PROGRIP MESH; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 12/13/2013

Event Type  Injury  

Event Description

Parietex progrip mesh inserted during open direct inguinal hernia repair.Pain following surgery.Severe burning and electric shock pain down the leg.Five years later ongoing issues with chronic daily pain affecting daily activities, relationship and work.

• Brand Name: PARIETEX PROGRIP MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8194435
• MDR Text Key: 131646346
• Report Number: MW5082554
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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; Disability
• Patient Age: 31 YR
• Patient Weight: 67