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

Model Number PCO12X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); Ambulation Difficulties (2544); Abdominal Distention (2601); No Code Available (3191)

Event Type  Death  

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. The product was used for therapeutic treatment of a ventral hernia. It was reported that after a procedure where this device was implanted, the patient experienced recurrent incisional hernia, stomach pain, swelling, intestinal protrusion, difficulty walking, continuous digestive problems, perforation of tissue/organs, adherence to tissue/organs, infection, nerve damage, subsequent surgeries and other complications. Treatment and potentially related procedures include additional surgery.

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. The product was used for therapeutic treatment of a ventral hernia. It was reported that after a procedure where this device was implanted, the patient experienced recurrent incisional hernia, stomach pain, swelling, intestinal protrusion, difficulty walking, continuous digestive problems, perforation of tissue and/or organs, adherence to tissue/organs, infection, and nerve damage. Treatment for these issues included subsequent surgeries. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration or any association with this device.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED 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 ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7695583
• MDR Text Key: 114220075
• Report Number: 9615742-2018-01607
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2019
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: POJ0410X
• 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: 03/05/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/21/2014
• 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: 07/17/2018 Patient Sequence Number: 1