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

Model Number	SYM4232
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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)
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8689729
• Report Number: 9615742-2019-02170
• Device Sequence Number: 14040808
• Product Code: FTL
• UDI-Device Identifier: 10884521190603
• UDI-Public: 10884521190603
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Weight: 122