MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO2015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Injury (2348); Weight Changes (2607); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the patient had to have a panniculectomy because fat necrosis had grown onto the mesh and was hurting. The patient has been hospitalized and has had two hernia repairs since then. Both times, additional mesh was installed. The event report type is serious injury and the event outcome is hospitalization.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown avenue; north haven, CT 06473 ; 2034925563
• MDR Report Key: 6637296
• MDR Text Key: 77450882
• Report Number: 9615742-2017-05158
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,OTHER,USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/13/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/31/2015
• Device MODEL Number: PCO2015
• Device Catalogue Number: PCO2015
• Device LOT Number: PKJ08661
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/13/2017 Patient Sequence Number: 1