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

Model Number	UNKNOWN PARIETEX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Scar Tissue (2060); Electrolyte Imbalance (2196); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); 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 left inguinal hernia.It was reported that after a procedure where this device was implanted, the patient experienced incarcerated left inguinal hernia, intermittent small-bowel obstruction due to adhesions, infected prosthetic mesh the abdominal wall; recurrence; pain; extensive enterolysis with enterectomy; fistula; serosal tears; multiple abscess; small bowel resection.After the original procedure additional surgeries were performed, including revision.
Additional Manufacturer Narrative
Additional information: b2, b5, d8, e1 (initial reporter: facility name, street 1, city, region, postal code), h6 (added patient and imf codes).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.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced mental pain, pain, impairment, loss of enjoyment of life, adhesions, recurrence, infection, fistula, serosal tears, abscess, enterectomy.Post-operative patient treatment included revision surgery, enterolysis, and small bowel resection.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced heavy growth bacteroides thetaiotaomicron, heavy growth klebsiella oxytoca, central fluid density, abnormal wbc, bun and creatinine, streptococcus intermedius, foreign body giant cell granulomatous reaction, fibrosing granulation tissue, focally ulcerated, draining fistulas, mucoid purulent drainage, hydrocele, ileus, transient confusion, malodororous yellow drainage, malodorous fibrinous exudate, blood-tinged drainage, non-healing wound, scarring, hematoma,wound drainage, small bowel obstruction, diastases recti, inflammation, enlarged prostate, mental pain, pain, impairment, loss of enjoyment of life, adhesions, recurrence, infection, fistula, serosal tears, and abscess.Post-operative patient treatment included lap lysis of adhesions, antibiotics, ct scan, antimicrobial dressing, repair of enterotomy, pain medication, pca pump, ng tube, supplemental oxygen, wound care, dressing changes, removal of sutures, mesh debridement, revision surgery, enterolysis, home health assistance, mesh removal, hernia repair with new mesh, home health, and small bowel resection.
Additional Manufacturer Narrative
H6 (patient codes, imf codes, updated ime e2402 to include "enlarged prostate, abnormal wbc and creatinine, hydrocele, ileus").Correction: d4 (model #, and catalog # updated to "unknown parietex", lot number updated to unknown).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.
Additional Manufacturer Narrative
Additional info: b5, b7, h6 (patient codes, imf codes, ime e2402: "enlarged prostate").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.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced wound drainage, small bowel obstruction, diastases recti, inflammation, enlarged prostate, mental pain, pain, impairment, loss of enjoyment of life, adhesions, recurrence, infection, fistula, serosal tears, abscess, enterectomy.Post-operative patient treatment included revision surgery, enterolysis, mesh removal, hernia repair with new mesh, home health, and small bowel resection.

• Brand Name: PARIETENE
• 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: 7586992
• Report Number: 9615742-2018-01261
• Device Sequence Number: 10799127
• Product Code: FTL
• UDI-Device Identifier: 20884521214900
• UDI-Public: 20884521214900
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/30/2023

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 Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Device Lot Number: SOI0519X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 11/23/2022; 08/09/2023; 08/16/2023
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 11/28/2022; 08/11/2023; 08/30/2023
• 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; Other; Disability
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White