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

Model Number UNKNOWN PARIETEX

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

Patient Problems Arrhythmia (1721); Hematoma (1884); Pneumonia (2011); Post Operative Wound Infection (2446)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

Title robotic-assisted ventral hernia repair with surgical mesh: how i do it and case series of early experience source anz j surg, 2019 (1-7) date of publication: 11 december 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of the study performed from may 2015 to august 2018, 50 patients underwent robotic assisted ventral hernia repair post -operative a procedure, out of 50 patients, 2 patients had a recurrence with a extended hospital stay of 3 days, 2 had a minor wound infection, 1 had aspiration pneumonia, 1 had ileus arrhythmias, 1 had ileus and seroma, and 1 had arrhythmia and abdominal wall hematoma.

• Brand Name: UNKNOWN PARIETEX
• 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: 8573166
• MDR Text Key: 143819897
• Report Number: 9615742-2019-01567
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2019
• 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; Other
• Patient Age: 65 YR