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

Model Number SYM1510F

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

Patient Problems Fistula (1862); Tissue Damage (2104); No Code Available (3191)

Event Date 11/22/2019

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, postoperative from laparoscopic esophageal hernia surgery through laparoscopic nissen fundoplication, patient had tissue damage - fistulous hole on distal esophagus and the enterocutaneous fistula.The patient had to be re-hospitalized.An endoscopy and fistula treatment had to be performed to resolve the issue.

• Brand Name: SYMBOTEX
• 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: 9788229
• MDR Text Key: 182112047
• Report Number: 9615742-2020-00547
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190382
• UDI-Public: 10884521190382
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131969
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SYM1510F
• Device Catalogue Number: SYM1510F
• Device Lot Number: PQJ0405X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Date Device Manufactured: 11/03/2016
• 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: 46 YR
• Patient Weight: 58