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

Model Number SYM3020

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Vomiting (2144); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Blood Loss (2597); Abdominal Distention (2601); Weight Changes (2607); 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 patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was recurrent ventral incisional hernia.The procedure performed was open ventral hernia repair with bilateral transversus release (component separation) and placement of mesh.The patient experienced surgical revision, evacuation of hematoma, recurrence repair, pain, bleeding, obstruction, and infections.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced a hematoma, recurrence, open wound, pain, bleeding, obstruction, and infections.Post-operative patient treatment included revision surgery, evacuation of hematoma, wound vac, and recurrence repair.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 ventral incisional hernia.It was reported that after the implant, the patient experienced hematoma, recurrence, open wound, pain, bleeding, mrsa, obstruction, chronic draining sinus tracts, abdominal distention, balled mesh, abdominal pain preventing sleep, nausea, vomiting, hospitalization, adhesions, obesity, scar tissue, inflamed abdominal wall and chronic infections.Post-operative patient treatment included revision surgery, evacuation of hematoma, wound vac, mesh removal, exploratory laparotomy, truncal component separation, cord lipoma resection, excision of abdominal wall and recurrent hernia repairs with additional implants.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 7449496
• MDR Text Key: 106134115
• Report Number: 9615742-2018-00955
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190511
• UDI-Public: 10884521190511
• Combination Product (y/n): N
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: SYM3020
• Device Catalogue Number: SYM3020
• Device Lot Number: POG0099X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/21/2018
• Supplement Dates Manufacturer Received: 06/19/2019; 06/19/2019
• Supplement Dates FDA Received: 01/15/2020; 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 113