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

Model Number	TEC3030
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Syncope (1610); Achalasia (1692); Adhesion(s) (1695); Hematoma (1884); Nausea (1970); Discharge (2225); Hernia (2240); Injury (2348); Disability (2371); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a ventral open hernia repair with mesh.She had revision surgery 10 months post-surgery.The patient experienced surgical revision, abdominal wall wound, and dense adhesions.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of ventral hernia.It was reported that after implant, the patient experienced recurrence, open wound of abdominal wall, balled mesh, dense adhesions, mesh migration.Post-operative patient treatment included revision surgery, excision of mesh, hernia repair with mesh, abdomen debridement of wound, dense adhesions released between greater omentum and anterior abdominal wall adjacent to mesh, wound vac.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of ventral hernia.It was reported that after implant, the patient experienced recurrence, open wound of abdominal wall, balled mesh, dense adhesions, mesh migration, discharge, hematoma, nausea, syncope, difficulty eating, intractable gastroesophageal reflux disease, achalasia, fibrosis, fibrotic pulmonary parenchyma.Post-operative patient treatment included revision surgery, excision of mesh, hernia repair with mesh, abdomen debridement of wound, dense adhesions released between greater omentum and anterior abdominal wall adjacent to mesh, wound vac and feeding jejunostomy tube insertion.Concomitant device: large ventralex patch.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7299407
• Report Number: 9615742-2018-00396
• Device Sequence Number: 1250027
• Product Code: FTL
• UDI-Device Identifier: 10884521180031
• UDI-Public: 10884521180031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: 06/28/2018
• Device Model Number: TEC3030
• Device Catalogue Number: TEC3030
• Device Lot Number: SNF0763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 10/28/2019; 12/19/2019
• 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: Other; Required Intervention
• Patient Age: 61 YR