MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMPOSITE MESH

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/30/2014

Event Type  Injury  

Event Description

I had hernia repair surgery and implanted with parietx composite mesh.Hospitalized once for infection and then had to have the mesh surgically removed after another infection.

• Brand Name: PARIETEX COMPOSITE MESH
• Type of Device: MESH
• Manufacturer (Section D): SOFRADIM PRODUCTION
• MDR Report Key: 4609208
• MDR Text Key: 5633016
• Report Number: MW5041457
• 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: 03/10/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR
• Patient Weight: 143