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

Model Number PCO1510

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Erythema (1840); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Hernia (2240); Ulcer (2274); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Constipation (3274); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced chronic open draining sinus, serosal tear, mesh failure, mesh detachment, adhesions, recurrence, obstruction, infection, open wound, fistula, abdominal pain, pain, inflammation, and abscess.Post-operative patient treatment included wound treatment, mesh revision, removal of mesh, hernia repair with new mesh, icu admittance for 2 days, lysis of adhesions, debridement of wound, repair of serosal tears, placement of drains and wound vac, incision and drainage of abscess, ventilator use, and prolonged use of antibiotics.

Manufacturer Narrative

Additional info: a1, a4, a5b, b5, b6, b7, h4, h6 (patient codes, device codes, ime e2402: irregular bowel movements, induration).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 Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced chronic open draining sinus tract, serosal tear, mesh failure, mesh detachment, adhesions, recurrence, obstruction, infection, open wound, fistula, abdominal pain, pain, inflammation, abscess, diastasis of the rectus muscle, fluid collection, seroma, mrsa, chronic ulcer, scarring, fibrous tissue, soreness, swelling, irregular bowel movements, constipation, diarrhea, vomiting, weakness, nonhealing wound, redness/erythema, clear drainage, cellulitic changes, purulent fluid, fistulous tract, induration, attenuation thinning of fascia, tenderness, distention, protrusion in central abdomen, wound dehiscence, mesh not well incorporated, scar tissue.Post-operative patient treatment included wound treatment, mesh revision, removal of mesh, hernia repair with new mesh, icu admittance for 2 days, lysis of adhesions, debridement of wound, repair of serosal tears, placement of drains and wound vac, incision and drainage of abscess, ventilator use, prolonged use of antibiotics, ct scan, pain medication, hospitalization, release of small bowel obstruction, partial removal of mesh, exploratory lap, bilateral myocutaneous advancement flaps, excision of fistula, sedation, npo, iv fluids, use of abdominal binder, ng tube, iv pain, wound care, use of jp drain, epidural, bilateral anterior component separation for recurrent ventral hernia repair.

• Brand Name: MESH SOFRADIM- PARIETEX COMPOSITE MESH
• Type of Device: 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: 16208820
• MDR Text Key: 307729375
• Report Number: 9615742-2023-00066
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: PCO1510
• Device Catalogue Number: PCO1510
• Device Lot Number: PKF00313
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/26/2024
• Date Device Manufactured: 06/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: Black Or African American