MAUDE Adverse Event Report: MEDTRONIC/ COVIDIEN PARIETEX HERNIA MESH; MESH, SURGICAL, POLYMERIC

Device Problem Folded (2630)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 09/08/2014

Event Type  Injury  

Event Description

A surgeon implanted a 15x13cm covidien parietex mesh for my small inguinal hernia.I got severe abdominal and groin pain.Had two surgeries to get it removed, but still in terrible pain.The mesh had crumbled and folded.

• Brand Name: PARIETEX HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC/ COVIDIEN
• MDR Report Key: 7108620
• MDR Text Key: 94667406
• Report Number: MW5073914
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 30 YR
• Patient Weight: 85