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

Model Number PCO15

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Adhesion(s) (1695); Foreign Body Reaction (1868); Granuloma (1876); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Injury (2348); Impaired Healing (2378); Fibrosis (3167); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

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 laparoscopic therapeutic treatment of an incisional ventral hernia.It was reported that after implant, the patient experienced abscess, adhesions, pain, seroma, and infected mesh.Post-operative patient treatment included revision surgery, admission to hospital, antibiotics, abscess drained, wound vac, removal of mesh, and small bowel resection with side-to-side anastomosis.

Manufacturer Narrative

Additional information: a4 (weight in lbs.).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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional ventral hernia.It was reported that after implant, the patient experienced abscess, adhesions, pain, seroma, infected mesh, recurrence, defective mesh, foreign body reaction, inflammation, hemorrhage, mesh migration, necrosis, fibrofatty soft tissues, fibrosis, foreign body granulomas, scar tissue, and open wound.Post-operative patient treatment included revision surgery, admission to hospital, antibiotics, abscess drained, wound vac, removal of mesh, small bowel resection with side-to-side anastomosis, hernia repair with new mesh, laparotomy, secondary abdominal wound closure, lysis of adhesions, holes in flaps closed with sutures, and flap advancement muscle rectus abdominis separation component.

• 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
• MDR Report Key: 10670217
• MDR Text Key: 211023359
• Report Number: 9615742-2020-02333
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: PCO15
• Device Catalogue Number: PCO15
• Device Lot Number: PHH00186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PROTACK (LOT#UNKNOWN).; UNKNOWN PROTACK (LOT#UNKNOWN)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 118