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

Model Number SYM2015

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Anemia (1706); Arteriosclerosis (1722); Atrial Fibrillation (1729); Bacterial Infection (1735); Death (1802); Diarrhea (1811); Dyspnea (1816); Fistula (1862); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pleural Effusion (2010); Renal Failure (2041); Sepsis (2067); Vomiting (2144); Weakness (2145); Discharge (2225); Hernia (2240); Discomfort (2330); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544); Ascites (2596); Blood Loss (2597); No Code Available (3191); Constipation (3274)

Event Type  Death  

Manufacturer Narrative

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 therapeutic treatment of multiple ventral hernias.It was reported that after implant, the patient experienced infection, severe abdominal pain, diarrhea, tolerating little food and not walking, vomiting, suffered fall due to weakness, shortness of breath, gi infection, watery, bloody stools, mid abdominal mass markedly tender to palpation, coumadin toxicity, sepsis and abdominal wall abscess, atrial fibrillation, hypotension, lactatemia and leukocytosis, splenomegaly, subscapular fluid collection, gi hemorrhage, colonic fistula, c diff colitis, leukocytosis, lactic acidosis, acute renal failure, anemia due to blood loss, severe sepsis with acute organ dysfunction, severe protein calorie malnutrition, gram neg infection, pseudomonas infection, constipation, nausea when sees food, increase drainage from wound.Post-operative patient treatment included iv fluids and blood transfusion (2 units), incision and drainage of abdominal wall abscess, hospital stay, skilled level care, long term care facility, and patient passed away on (b)(6) 2017.Death certificate notes cause of death as abdominal wall abscess, colonic fistula and diverticulosis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 8998238
• MDR Text Key: 157688409
• Report Number: 9615742-2019-03086
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190450
• UDI-Public: 10884521190450
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: POL0671X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Date Device Manufactured: 01/07/2015
• 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): Death; Required Intervention
• Patient Weight: 129