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

Model Number SYM3420E

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Tissue Damage (2104); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was incisional hernia and umbilical hernia.The procedure performed was repair of incisional hernia with mesh, lysis of adhesions and repair of umbilical hernia with mesh.(b)(6) 2016 - approximately one-year and 3 ½ months after the (b)(6) 2014 mesh implantation.The patient underwent a surgical revision for exploratory laparotomy with extensive lysis of adhesions, incision and drainage of the abdominal wall with removal of infected prosthetic meshes, abdominal wall debridement including skin, umbilicus, subcutaneous tissue, myofascial tissue and hernia sac, and sutures, small bowel resection including meckel diverticulum and small bowel stricture with primary anastomosis, bilateral posterior rectus sheath component release, advancement and closure, hybridized with the transversus abdominis release in the subxiphoid area, for exclusion of peritoneal cavity form retromuscular space, repair of large recurrent chronically incarcerated incisional hernia with plication closure of white lateral abdominal wall defect with subsequent retromuscular placement of mesh and primary closure of autologous fascia over mesh with use of irrigations, activated autologous platelet rich plasma an drains.The pre-op diagnosis was large complex recurrent incisional hernia with symptoms of intermittent partial small -bowel obstruction; possible infected prosthetic mesh (fluid seen around mesh by ct imaging), significant risk factors and history.Active tobacco abuse with chronic obstructive pulmonary disease, history of postoperative respiratory issues.Morbid obesity with a body mass index approximately 34 kilograms per meters squared.The post-op diagnosis was infected prosthetic mesh (periumbilical dual layer or mesh with fluid and nonincorporated, but also some discolored fluid around area of larger mesh that occupies most of right greater than left upper abdominal wall).Large complex chronically incarcerated recurrent incisional hernia (large defect medial the mid upper abdominal mesh with smaller lateral defects and around infected mesh).Meckel's diverticulum with question stricture of small bowel just distal to the base of the diverticulum.Chronic obstructive pulmonary disease with active tobacco abuse and morbid obesity.The patient experienced adhesions; bowel removal, infection, mesh removal, recurrence, and revision.

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: 7332222
• MDR Text Key: 102181764
• Report Number: 9615742-2018-00487
• Device Sequence Number: 1
• Product Code: FTL
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: SYM3420E
• Device Catalogue Number: SYM3420E
• Device Lot Number: PNK0100X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2018
• Date Device Manufactured: 11/16/2013
• 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; Required Intervention
• Patient Age: 60 YR