MAUDE Adverse Event Report: SOFRADIM PARIETEX PROGRIP MESH

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/07/2013

Event Type  Injury  

Event Description

Had an inguinal hernia repair (b)(6) 2013 where parietex progrip mesh was used and after 3 to 4 weeks, i developed extreme debilitating pain at the surgery site and into the groin area.After many attempts to relieve the pain through pain management, with little to no relief, in (b)(6) of 2014, i had a second surgery to remove the mesh.

• Brand Name: PARIETEX PROGRIP MESH
• Type of Device: PARIETEX PROGRIP MESH
• Manufacturer (Section D): SOFRADIM; * ; *
• MDR Report Key: 4386930
• MDR Text Key: 16305190
• Report Number: MW5039928
• Device Sequence Number: 1
• Product Code: FTL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/30/2014

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
• Other Device ID Number: L0G15972
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 59 YR
• Patient Weight: 95