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

Model Number	PCO1510OSX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Pulmonary Infarction (2021); Tachycardia (2095); Urinary Retention (2119); Vomiting (2144); Chills (2191); Hernia (2240); Distress (2329); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant product: pco15x parietex pcox rnd 15 cm x1 (lot# pmi00457), pco1510x parietex pcox 15x10 cm x1 (lot# pnj0054x).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 ventral hernia and right/left inguinal hernias.It was reported that after implant, the patient experienced infection, segmental pulmonary emboli, atelectasis, slowly improving tachycardia, diarrhea, recurrence, oliguria [abnormally small amounts of urine], pain, nausea, vomiting, fever, chills, small bowel obstruction, abdominal pain, serosal traction tear, pulmonary infarcts, inflammation, air-fluid collection, and ileus.Post-operative patient treatment included revision surgery, picc line placed, ng tube, therapeutic anticoagulation for pe, iv hydration, analgesics, hernia repair with new mesh, admission to hospital, lysis of adhesions, serosal traction tear repaired, drain in place, and mesh removal.
Additional Manufacturer Narrative
Additional info: b5, b6, h6 (patient code, imf code, ime e2402 updated to include: "abnormal wbc and hemoglobin").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 ventral hernia and right/left inguinal hernias.It was reported that after implant, the patient experienced emotional distress, abnormal wbc and hemoglobin, infection, segmental pulmonary emboli, atelectasis, slowly improving tachycardia, diarrhea, recurrence, oliguria [abnormally small amounts of urine], pain, nausea, vomiting, fever, chills, small bowel obstruction, abdominal pain, serosal traction tear, pulmonary infarcts, inflammation, air-fluid collection, and ileus.Post-operative patient treatment included ct scan, revision surgery, picc line placed, ng tube, therapeutic anticoagulation for pe, iv hydration, analgesics, hernia repair with new mesh, admission to hospital, lysis of adhesions, serosal traction tear repaired, drain in place, and mesh removal.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a ventral hernia and right/left inguinal hernias.It was reported that after implant, the patient experienced emotional distress, abnormal wbc and hemoglobin, infection, segmental pulmonary emboli, atelectasis, slowly improving tachycardia, diarrhea, recurrence, oliguria, pain, nausea, vomiting, fever, chills, small bowel obstruction, abdominal pain, serosal traction tear, pulmonary infarcts, inflammation, air-fluid collection, and ileus.Post-operative patient treatment included ct scan, revision surgery, picc line placed, ng tube, therapeutic anticoagulation for pe, iv hydration, analgesics, hernia repair with new mesh, admission to hospital, lysis of adhesions, serosal traction tear repaired, drain in place, and mesh removal.
Additional Manufacturer Narrative
Correction: b2 (added life threatening), b5, h6 (imf code).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: mike bocchino ; 8200 coral sea st ne; mounds view,mn, CO 55112-4391 ; 8006464633
• MDR Report Key: 12320925
• Report Number: 9615742-2021-01946
• Device Sequence Number: 4542353
• Product Code: FTL
• UDI-Device Identifier: 10884521179691
• UDI-Public: 10884521179691
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 08/27/2025

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: 07/31/2014
• Device Model Number: PCO1510OSX
• Device Catalogue Number: PCO1510OSX
• Device Lot Number: PMG00606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/20/2025; 08/27/2025
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 08/21/2025; 08/27/2025
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White