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

Model Number	PCO2H3
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Obstruction/Occlusion (2422); Bowel Perforation (2668); 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
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 implant, the patient experienced adhesions, infected mesh, abscess, fistula, small bowel perforation, fibrosis, livery injury, hoarseness, reflux, reflux laryngitis, pain, fistulous tract, perforation, mesh migration, fibrotic scar tissue, purulent material, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, drainage of abscess, closure of small bowel perforation, esophagojejunoscopy, roux-en-y esophagojejunostomy, segmental small bowel resection of the roux-en-y esophagojejunostomy, and segmental resection of the roux-en-y loop containing the perforation and a fistula.
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.
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 implant, the patient experienced adhesions, infection/infected mesh, abscess, fistula, small bowel perforation, fibrosis, livery injury, hoarseness, reflux, reflux laryngitis, pain, fistulous tract, perforation, mesh migration, fibrotic scar tissue, purulent material, mesh erosion, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, drainage of abscess, closure of small bowel perforation, esophagojejunoscopy, roux-en-y esophagojejunostomy, segmental small bowel resection of the roux-en-y esophagojejunostomy, and segmental resection of the roux-en-y loop containing the perforation and a fistula.
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 implant, the patient experienced adhesions, infection/infected mesh, abscess, fistula, small bowel perforation, fibrosis, livery injury, hoarseness, reflux, reflux laryngitis, pain, fistulous tract, perforation, mesh migration, fibrotic scar tissue, purulent material, mesh erosion, small bowel obstruction, serosal injury, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, lysis of adhesions, drainage of abscess, closure of small bowel perforation, esophagojejunoscopy, roux-en-y esophagojejunostomy, segmental small bowel resection of the roux-en-y esophagojejunostomy, and segmental resection of the roux-en-y loop containing the perforation and a fistula.
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.

• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 11548192
• Report Number: 9615742-2021-00633
• Device Sequence Number: 4088055
• Product Code: FTL
• UDI-Device Identifier: 10884521178465
• UDI-Public: 10884521178465
• 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: 2009
• Device Explanted Year: 2017
• 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): 03/28/2022

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: 01/31/2011
• Device Model Number: PCO2H3
• Device Catalogue Number: PCO2H3
• Device Lot Number: PGA00451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 03/09/2022
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 07/29/2021; 03/29/2022
• 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: BARD SORBAFIX, REF: (B)(4), LOT: DATE0014; BARD SORBAFIX, REF: (B)(4), LOT: DATE0014
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG