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

Model Number PCO15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Necrosis (1971); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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. Product was used for laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, infected mesh, open abdominal wound, fat necrosis, hypotension, purulent discharge, mesh erosion and adhesions. Post-operative patient treatment included revision surgery, lysis of adhesions, wound vac application, and resection of mesh.

Manufacturer Narrative

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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Preoperative and postoperative diagnosis was ­­­­­­­­­ventral hernia, the procedure performed was laparoscopic v entral hernia repair. The patient has had multiple surgical revisions, recurrent hernia, and resection of mesh.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 7174628
• MDR Text Key: 109428852
• Report Number: 9615742-2018-00068
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2013
• Device Model Number: PCO15
• Device Catalogue Number: PCO15
• Device Lot Number: PIJ00389
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• 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: 01/09/2018 Patient Sequence Number: 1

Treatment

PCO1510(LOT#: PHJ00471); UNKNOWN PROTACK (LOT# UNKNOWN)