MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP 3D PY 30X20CM NO THRX1

Model Number PCO3020

Device Problems Device Issue (2379); Insufficient Information (3190)

Patient Problems Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 05/21/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: the patient is a middle aged gentleman with end-stage renal disease who has undergone multiple abdominal procedures including hernia repair approximately five years ago with parietex composite mesh.He has had a chronic draining sinus from the mid portion of his midline incision.He underwent a wound exploration approximately three years ago where some foreign material was removed, presumably mesh.The wound was closed, but he continued to have a chronic draining sinus that drained purulent material on a basically daily basis.This was causing significant compromise to his quality of life.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

As received via medwatch: removal of infected mesh.Infected parietex mesh with subfascial abscess.Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.

• Brand Name: PARIETEX COMP 3D PY 30X20CM NO THRX1
• Type of Device: PARIETEX COMP 3D
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4273982
• MDR Text Key: 12763303
• Report Number: 9615742-2014-00338
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: PJB00391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 76