MAUDE Adverse Event Report: COVIDIEN/ SOFRADIM PARIETEX HERNIA MESH

Model Number	60566569
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Hernia mesh failed needed new surgery on (b)(6) 2010.Used paritex mesh.First mesh was not found when they did 2 surgeries.Just had a cat scan done and they found it at the bottom of my stomach.

• Brand Name: PARIETEX HERNIA MESH
• Common Device Name: PARIETEX HERNIA MESH
• Manufacturer (Section D): COVIDIEN/ SOFRADIM
• MDR Report Key: 6559912
• Report Number: MW5069693
• Device Sequence Number: 18386782
• Product Code: FTL
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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
• Operator of Device: Health Professional
• Device Model Number: 60566569
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Weight: 84