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

Model Number	PCO3728X
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Aspiration/Inhalation (1725); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Dyspnea (1816); Ecchymosis (1818); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Fever (1858); Fistula (1862); Headache (1880); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Hyperemia (1904); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Itching Sensation (1943); Muscle Weakness/Atrophy (1967); Nausea (1970); Neuropathy (1983); Internal Organ Perforation (1987); Scar Tissue (2060); Tachycardia (2095); Vomiting (2144); Chills (2191); Electrolyte Imbalance (2196); Hernia (2240); Peritonitis (2252); Discomfort (2330); Impaired Healing (2378); Numbness (2415); Fungal Infection (2419); Diaphoresis (2452); Sleep Dysfunction (2517); Abdominal Cramps (2543); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Thrombosis/Thrombus (4440); Blister (4537); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced fluid collection, infection, abscess, purulent discharge, adhesions, fistula, serosal injuries, mental pain, impairment, loss of enjoyment of life, disability, low lung volumes, atelectasis, aspiration, labs abnormal for lactate; hemoglobin; wbc; sodium; hematocrit; total bilirubin; ast; alt; calcium; potassium; glucose; prothrombin time; inr; fibrinogen; platelets; c-reactive protein; magnesium; phosphorus; albumin, hernia recurrence, small bowel perforation, gaseous/air collection, fibrous connective tissue, inflammation, pneumoperitoneum, mycobacterium fortuitum, strep, haemophilis parainfluenzae, klebsiella aerogenes, lactose fermenting gram negative rods, actinomyces species, ceftriaxone, serratia, bacillus, bacteremia, fibrous serosal adhesions, edema, fistulous tract, hyperemia, transverse colitis, ileus, scarring, ischemic changes, candida albicans, tachycardia, fever, abdominal pain, bleeding, peritonitis, leukocytosis, diaphoresis, abdominal soreness/tenderness, distention, opened wound, induration, erythema, thrombocytosis, bilious drainage, bulge, nausea, hematoma with ecchymosis, blood clots, decreased energy, difficulty sleeping, wound dehiscence, fluid filled bump at edge of incision, wound leaking pus, loculations, vomiting, chills, swelling, hostile abdomen, nociceptive neuropathic pain, tongue perioral numbness, abdominal cramping, night sweats, itchy, agitation, failure to thrive, weakness, limited physical activity, feeling ill, headache, bloating, shortness of breath, diarrhea, boggy tissue, slightly blackened tissue around site with serosanguinous drainage, fungal infection, electrolyte imbalance, bullae, febrile, fatigue, fluctuance, muscle spasms.Post-operative patient treatment included removal of mesh, fluid collection drainage, two small bowel resections with anastomosis, multiple take down of adhesions, serosal injuries repaired, hernia repair with mesh, x-ray, ct scan, ultrasound, picc line placement, multiple exploratory lap, mesh revision, icu, iv fluids, pca, iv pain medication, iv antibiotics, ng tube, abdominal binder, supplemental oxygen, drain placement, wound care, npo, gi rest, iv anti-nausea medication, wound exploration, evacuation of hematoma, blood clots extruded, component separation, use of jp drains, soft tissue drainage catheter placement under ct guidance, multiple hospitalizations, lidocaine infusion, parenteral nutrition, tpn for nutritional supplementation, iv anti-fungal medication, electrolyte replacement, bowel rest, nerve block, fistula tract excision, complex abdominal wall closure, wound vac, drainage of abscess with drain placement, urethral catheterization, pt.
Additional Manufacturer Narrative
H6 ime e2402: labs abnormal for total bilirubin; ast; alt; glucose; prothrombin time; inr; fibrinogen; platelets; lactate; hemoglobin; wbc; sodium; hematocrit; c-reactive protein; albumin, gaseous/air collection, pneumoperitoneum, transverse colitis, ileus, leukocytosis, induration, thrombocytosis, failure to thrive, boggy tissue, blackened tissue, fluctuance, low lung volumes, atelectasis 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.
Additional Manufacturer Narrative
Additional info: d4 (expiration date, lot #, unique identifier (udi) #), & h4.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.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 ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19735815
• Report Number: 9615742-2024-00967
• Device Sequence Number: 18236516
• Product Code: FTL
• UDI-Device Identifier: 10884521179653
• UDI-Public: 10884521179653
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 03/21/2025

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: 06/30/2019
• Device Model Number: PCO3728X
• Device Catalogue Number: PCO3728X
• Device Lot Number: POG0476X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 07/26/2014
• 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: UNKNOW PROTACK
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Hispanic
• Patient Race: White