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

Model Number	SYM3728
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent an exploratory laparotomy, extensive adhesiolysis, removal of old mesh and repair of recurrent incarcerated incisional hernia with mesh.His original surgery was 11 months ago.The patient experienced pain, adhesions, and hernia recurrence.
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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent the repair of incisional hernias with mesh.He had revision surgery 11 months post-surgery.The patient experienced pain, adhesions, and hernia recurrence, bowel disruption, seroma, fistula, obstruction and infections.It has been noted that the patient has expired.The patient had expired due to cardio respiratory failure & acute renal disease.

• 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: 7220018
• Report Number: 9615742-2018-00288
• Device Sequence Number: 111437
• Product Code: FTL
• UDI-Device Identifier: 10884521190566
• UDI-Public: 10884521190566
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 12/31/2016
• Device Model Number: SYM3728
• Device Catalogue Number: SYM3728
• Device Lot Number: PNL0644X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 06/12/2019
• 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; Other; Required Intervention
• Patient Age: 55 YR