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

Model Number UNKNOWN PARIETEX PRODUCT

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

Patient Problems Awareness during Anaesthesia (1707); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Seroma (2069)

Event Date 08/30/2022

Event Type  Injury  

Event Description

According to the literature source of study performed between august 2013 and february 2020 regarding the compared outcome of emergency or acute ventral herniation and elective ventral hernia repair on 1307 patients.The study was of two groups depending on the urgency of hernia repair: 147 patients were operated in an emergency setting and 1160 patient were scheduled for elective surgery.Mesh was used in 94 patients (9 for emergency setting and 85 for elective surgery).There were complications included: bleeding, seroma, chronic pain, infection, hernia recurrence.Chronic pain was treated with analgesia, anesthesia or treatment operation and recurrent hernia required re-operation.There was one postoperative death in the emergency repair group, with cause of death that was not specified and no device allegation.Other complications not related to the device included: ileus, cardiac complications, and pulmonary complications.

Manufacturer Narrative

Concomitant medical products: product id: unknown-ticron unknown ticron, serial #:unk, lot#: unk.Title: emergency repair and smoking predict recurrence in a large cohort of ventral hernia patients source: hernia (2022) 26:1337¿1345.Https://doi.Org/10.1007/s10029-022-02672-0.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15880741
• MDR Text Key: 304474457
• Report Number: 9615742-2022-01129
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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: 11/10/2022
• 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): Other
• Patient Sex: Male