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

Model Number	PCO2H3
Medical Device Problem Codes	Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fatigue (1849); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Chills (2191); Hernia (2240); Discomfort (2330); Deformity/ Disfigurement (2360); Weight Changes (2607); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
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 hiatal hernia.It was reported that after the implant, the patient experienced mental pain/anguish, physical pain, permanent injury, physical deformity, abdominal pain, nausea, chills, loss of appetite, weight loss, infection, scarring, adhesions, abscess, discomfort, failure of mesh, defective mesh, disfigurement, mesh erosion, mesh contraction, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic, nerve damage, and lack of energy.Post-operative patient treatment included revision surgery, drainage of infection, pain medication, operations to attempt to repair organs/tissue/nerve damage, and removal of mesh.
Additional Manufacturer Narrative
Additional information: a2, a3, a4, b5, b7, h6(patient codes), additional codes 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 therapeutic treatment of a hiatal hernia.It was reported that after the implant, the patient experienced mental pain/anguish, physical pain, permanent injury, physical deformity, abdominal pain, nausea, chills, loss of appetite, weight loss, infection, scarring, adhesions, abscess, discomfort, failure of mesh, defective mesh, disfigurement, mesh erosion, mesh contraction, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic, nerve damage, and lack of energy.Post-operative patient treatment included revision surgery, drainage of infection, pain medication, operations to attempt to repair organs/tissue/nerve damage, diagnostic laparoscopy, blake drains, and removal of mesh.
Additional Manufacturer Narrative
Additional information: h6 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.

• 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: 11118692
• Report Number: 9615742-2021-00024
• Device Sequence Number: 11772941
• Product Code: FTL
• UDI-Device Identifier: 10884521178465
• UDI-Public: 10884521178465
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• 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): 10/16/2024

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: 12/30/2013
• Device Model Number: PCO2H3
• Device Catalogue Number: PCO2H3
• Device Lot Number: PJA00069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 09/25/2024; 10/09/2024
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 10/01/2024; 10/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG