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

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

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.   due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hernia. It was reported that after implant, the patient experienced dense adhesions and fistula. Post-operative patient treatment included small bowel resection.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.   due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced dense adhesions, subserosal tissues associated with fibrosis, granulomatous foreign body reaction, weight loss, panniculus, and fistula. Post-operative patient treatment included small bowel re section, abdominal panniculectomy, lap and open ventral hernia repair, separation of components with mobilization of skin flaps with tissue rearrangement, small bowel resection, repair of colotomy, lap to open ventral hernia repair, placement of ventralight mesh, mobilization of skin flaps, tissue arrangement, complex wound closure, mesh explanation, mobilization of tissue flap, complex wound closure and lysis of adhesions relevant tests/laboratory data, including dates: (b)(6) 2014: pathology report- small bowel shows foreign material in subserosal tissues associated with fibrosis and granulomatous foreign body reaction probably representing mesh material.

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.

• 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: 109780648
• 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: Non-Healthcare Professional
• 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

• 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