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

Model Number	PCOPM15
Medical Device Problem Codes	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); Emotional Changes (1831); Fever (1858); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Seroma (2069); Tachycardia (2095); Vomiting (2144); Chills (2191); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); 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 a parastomal hernia.It was reported that after implant, the patient experienced chronic pain, multiple small bowel obstructions, multiple abscesses, adhesions and recurrence.The device had been used with covidien tacking devices (lot# n0b0513, p9c1251) and c-qur v-patch mesh 4.3x4.3 cm (ref# (b)(4), lot# 10580516037).Post-operative patient treatment included mesh explant and multiple surgical revisions ((b)(6) 2010, (b)(6) 2012, (b)(6) 2012, (b)(6) 2013, (b)(6) 2016, (b)(6) 2017).
Additional Manufacturer Narrative
Additional information: concomitant device: abstack20 (lot#: n0b0513); 174006(lot#: p9c1251); c-qur v-patch mesh 4.3x4.3 cm (ref# 31200, lot# 10580516037 patient code-c64343(leukocytosis).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 a parastomal hernia.It was reported that after implant, the patient experienced chronic pain, multiple small bowel obstructions, multiple abscesses, fluid collection, seroma, adhesions, abdominal pain, nausea, vomiting, fever, chills, tachycardia, leukocytosis, necrosis, ascites,small perforation, minor enteric spillage, and recurrence.Post-operative patient treatment included mesh explant, repair of hernia with mesh, lysis of adhesions, excision of mesh and tacks, reduction of parastomal hernia, enterorrhaphy, long tube decompression of small bowel, and multiple surgical revisions.The device had been used with c-qur v-patch mesh 4.3x4.3 cm (ref# 31200, lot# 10580516037).
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a parastomal hernia.It was reported that after implant, the patient experienced multiple small bowel obstructions, multiple abscesses, fluid collection, seroma, adhesions, abdominal pain, nausea, vomiting, fever, chills, tachycardia, leukocytosis, necrosis, ascites, small perforation, minor enteric spillage, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and recurrence.Post-operative patient treatment included mesh explant, repair of hernia with mesh, lysis of adhesions, excision of mesh and tacks, reduction of parastomal hernia, enterorrhaphy, long tube decompression of small bowel, and multiple surgical revisions.
Additional Manufacturer Narrative
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: additional 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 a parastomal hernia.It was reported that after implant, the patient experienced multiple small bowel obstructions, multiple abscesses, fluid collection, seroma, adhesions, abdominal pain, nausea, vomiting, fever, chills, tachycardia, leukocytosis, necrosis, ascites, small perforation, minor enteric spillage, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and recurrence.Post-operative patient treatment included mesh explant, repair of hernia with mesh, lysis of adhesions, excision of mesh and tacks, reduction of parastomal hernia, enterorrhaphy, long tube decompression of small bowel, multiple surgical revisions, x-ray, & ct scan.

• 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 ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8290086
• Report Number: 9615742-2019-00196
• Device Sequence Number: 1953274
• Product Code: FTL
• UDI-Device Identifier: 10884521177758
• UDI-Public: 10884521177758
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/29/2023

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 Expiration Date: 05/31/2013
• Device Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Device Lot Number: PIF00188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 11/06/2019; 01/26/2022; 11/15/2023
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 11/25/2019; 02/10/2022; 11/29/2023
• Date Device Manufactured: 06/17/2008
• 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; Disability
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White