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

Model Number	PCO3020FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Tract Infection (2120); Vomiting (2144); Hernia (2240); Impaired Healing (2378); Fungal Infection (2419); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Ascites (2596); Fluid Discharge (2686); Hallucination (4428); 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 therapeutic treatment of a hernia.It was reported that after implant, the patient experienced fluid collection, infected mesh, inflammation, seroma, abscess, hernia recurrence, staph aureus, scarring, yellow serous fluid, abdominal pain, vomiting, discharging sinuses, pain, chronic abdominal wound with purulent discharge, uti, bladder fistula, erythema, swelling, fungal infection, severe pain with walking, skin irritation, wound infection, thrush, small bowel obstruction, adhesions, agitation, physical aggression, delirium, hallucinations, & incontinence.Post-operative patient treatment included ct scan, use of indwelling drain, multiple hospitalizations, antibiotics, incision <(>&<)> drainage of abdominal wound abscess, yellow serous fluid aspirated, imaging, pain medication, exploration of abdominal wall sinus, wound care, wound vac, debridement of abdominal wound sinus, mesh removal, repair of bladder fistula, reconstruction of abdominal wall, tackers removed, ultrasound guided drainage of seroma, antifungal medication, seroma wall excision, excess skin excised, multiple hernia repair with meshes, iv antibiotics, drain placement, laparotomy, & primary repair of incisional hernia.
Additional Manufacturer Narrative
H6 ime e2402: sinus, physical aggression 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
Correction: during a detailed review of the received medical records, an additional incident was identified involving a medtronic mesh for the patient reported under regulatory report #9615742-2024-01384.No device allegation were reported by the attorney for this incident.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20323416
• Report Number: 9615742-2024-01386
• Device Sequence Number: 7669512
• Product Code: FTL
• UDI-Device Identifier: 10884521179844
• UDI-Public: 10884521179844
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• 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): 10/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: PCO3020FX
• Device Catalogue Number: PCO3020FX
• Device Lot Number: PPA0244X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 01/22/2015
• 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: PROLENE MESH.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 126 KG