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 Death (1802); Dysphagia/ Odynophagia (1815); Internal Organ Perforation (1987); Hernia (2240); Laceration(s) of Esophagus (2398); No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Title: subjective outcome after laparoscopic hiatal hernia repair for intrathoracic stomach source langenbecks arch surg (2017) 402:521¿530. Date of publication: 9 november 2016. (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

According to the study, postoperative intra thoracic stomach hiatal hernia repair procedure, between january 2004 and january 2015, eighty-six patients underwent laparoscopic repair for intra thoracic stomach, from which, one patient died during surgery. Upon medical review; the event of a patient death and its reported severity is not related to the device or therapy because a perforation of the aorta occurred intraoperatively during mobilization of the esophagus, and the damage to the aorta was too extensive and the patient died during surgery. An autopsy revealed an aneurysm, which was unknown prior to surgery. The patient's death is not device related.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9578489
• MDR Text Key: 178340639
• Report Number: 9615742-2020-00059
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• 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: 12/13/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 01/10/2020 Patient Sequence Number: 1