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

Model Number SYM15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Perforation (2001); Sepsis (2067); Septic Shock (2068); Tachycardia (2095); Hernia (2240); Peritonitis (2252); Injury (2348); Obstruction/Occlusion (2422); Respiratory Failure (2484); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: unknown absorbatack (lot# unknown), unknown protack (lot# unknown).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, infection, peritonitis, sepsis, perforated diverticulitis, septic shock, acute respiratory failure, pancytopenia, tachycardia, acute on chronic kidney disease, elevated lactate, and bowel obstruction.Post-operative patient treatment included revision surgery, admission to hospital, enterotomy repaired, icu, requiring vasopressor management, resuscitation, antibiotic, antiviral therapy, and mesh removal.

• 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: 10740912
• MDR Text Key: 213215831
• Report Number: 9615742-2020-02396
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190368
• UDI-Public: 10884521190368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM15
• Device Catalogue Number: SYM15
• Device Lot Number: PPB0530X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• 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; Life Threatening; Required Intervention
• Patient Weight: 125