MAUDE Adverse Event Report: COVIDIEN/ SOFRADIM PARIETEX HERNIA MESH

Model Number 60566569

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2009

Event Type  Injury  

Event 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
• Type of Device: PARIETEX HERNIA MESH
• Manufacturer (Section D): COVIDIEN/ SOFRADIM
• MDR Report Key: 6559912
• MDR Text Key: 75011443
• Report Number: MW5069693
• Device Sequence Number: 1
• Product Code: FTL

Combination Product (Y/N)

• 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: 05/09/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/09/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 60566569
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 05/09/2017 Patient Sequence Number: 1