MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

Model Number UNKNOWN PARIETEX PRODUCT

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

Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Seroma (2069); Hernia (2240); Peritonitis (2252); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Bowel Perforation (2668); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Title: laparoscopic treatment of incisional and ventral hernia source: society of laparoscopic <(>&<)> robotic surgeons.Published by the society of laparoscopic <(>&<)> robotic surgeons, doi: 10.4293/js ls.2021.00007 april-june 2021 volume 25 issue.2 (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between january 1, 2001 and december 31, 2017, a retrospective study evaluated outcomes of patients who underwent laparoscopic repair of abdominal wall or incisional hernia using the laparoscopic intraperitoneal onlay mesh technique, in all cases, the procedures were approached laparoscopically, the composite mesh was used and fixed in place with either absorbable tacks on 256 patients, titanium tacks on 1383 patients and sutures or fibrin glue on 29 patients.There were 1777 patients in the study and complications included: intraoperative bleeding and bowel perforation, seroma, hematoma, mesh infection, bowel occlusion, peritonitis and hernia recurrence.Conversion to open and reoperations were reported.Patients with mesh bulging underwent ct scan for diagnoses and reoperation for recurrence.Postoperative pain was measured through both a vrs (verbal rating scale) and an nrs (numeric rating scale).With the vrs score, postoperative pain was absent in 21.2% of patients, mild in 59.5%, moderate in 18.9% and severe in 0.5%.Using nrs categories, patients reported no pain in 20.4% of cases, mild in 61.2%, moderate in 18.0% and severe in 0.5%.The median length of hospital stay was 2 days.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: 12447246
• MDR Text Key: 270549770
• Report Number: 9615742-2021-02171
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• 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: 61 YR