MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE; MESH, SURGICAL, POLYMERIC

Model Number PP1510

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

Patient Problems Bacterial Infection (1735); Seroma (2069)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, following a laparoscopic inguinal hernia plus an open umbilical hernia, the patient developed a seroma over the mesh site.The seroma was aspirated twice, and the case was completed.The patient was in hospital for three days following the initial aspiration for iv antibiotics, and then repeat aspiration about one week later.However, after 5-6 days, the patient developed an infection with mycobacterium goodii.The patient had to have a second operation to remove the infected mesh.This resulted to extended surgical time of more than 30 minutes.Also, the patient had to stay in hospital for additional four days on second readmission with drain to manage infected seroma.The patient will be on antibiotics for next 3-4 months.

• Brand Name: PARIETENE
• 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: 11378155
• MDR Text Key: 233478542
• Report Number: 9615742-2021-00394
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PP1510
• Device Catalogue Number: PP1510
• Device Lot Number: STL1061X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Date Device Manufactured: 12/04/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 90