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

Model Number	PCO2H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: j<(>&<)>j evicel device (product id: 3905, lot#: u15f760); abstack15 abs fixation device 15 tacks(product id: abstack15; lot#: n5d0949mx).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 laparoscopic therapeutic treatment of a hiatal hernia.It was reported that after implant, the patient experienced recurrence, adhesions, and lung was adhered to hernia sac.Post-operative patient treatment included revision surgery.
Additional Manufacturer Narrative
Additional information: a4, b5, b7, d8, e1, g1, h6 (ime, imf codes, ime e2402: retching attacks) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a hiatal hernia.It was reported that after implant, the patient experienced recurrence, adhesions, lung was adhesed to hernia sac, pain, chronic nausea, fibrosis, scar tissue, retching attacks, inflammation.Post-operative patient treatment included revision surgery, left thoracotomy, hernia repair with new mesh, belsey iv fundoplication and egd, medication.
Additional Manufacturer Narrative
Additional information: a4, b5, b7 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a hiatal hernia.It was reported that after implant, the patient experienced recurrence, adhesions, lung was adhesed to hernia sac, pain, chronic nausea, fibrosis, scar tissue, retching attacks, inflammation, nausea.Post-operative patient treatment included revision surgery, left thoracotomy, hernia repair with new mesh, belsey iv fundoplication and egd, medication, gastropexy.

• Brand Name: PARIETEX
• Common Device Name: 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: justin ellis ; 60 middletown ave.; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 10584066
• Report Number: 9615742-2020-02220
• Device Sequence Number: 19610576
• Product Code: FTL
• UDI-Device Identifier: 10884521178458
• UDI-Public: 10884521178458
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 06/30/2019
• Device Model Number: PCO2H1
• Device Catalogue Number: PCO2H1
• Device Lot Number: POG0060X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 07/17/2024; 08/28/2024
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 08/01/2024; 09/04/2024
• Date Device Manufactured: 07/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE SECTION H10..
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG