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

Model Number SYM4232

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Ischemia (1942); Nausea (1970); Pain (1994); Renal Disease, End Stage (2039); Seroma (2069); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); No Code Available (3191)

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 a recurrent incisional hernia with incarcerated bowel.It was reported that after implant, the patient experienced pain, adhesions, hernia recurrence, bowel disruption, abdominal wall seroma, fistula, obstruction, exposed mesh, purulent discharge with foul odor, open abdominal wound, hematemesis, abdominal pain, nausea, vomiting, ischemia, fascitis, and infections.Post-operative patient treatment included revision surgeries, additional implant for recurrence repairs, incision and drainage of seroma, debridement, placement of wound vac, mesh removal, abdominal wound skin graft, exploratory laparotomy, extensive adhesiolysis, small bowel resection with anastamosis and abdominal wash out with 3 liters of saline.Information received indicates the patient is deceased.The patient expired due to cardio respiratory failure & acute renal disease.It is unknown at this time if the device caused or contributed to the event.

• 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: 8689729
• MDR Text Key: 147700759
• Report Number: 9615742-2019-02170
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190603
• UDI-Public: 10884521190603
• 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
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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: SYM4232
• Device Catalogue Number: SYM4232
• Device Lot Number: PNJ0884X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Date Device Manufactured: 11/04/2013
• 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): Death; Required Intervention
• Patient Weight: 122