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

Model Number PCO12X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Purulent Discharge (1812); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Necrosis (1971); Pain (1994); Perforation (2001); Seroma (2069); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559); 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 the overlay implant, the patient experienced infected mesh, splenic laceration, adhesions, fistula, seroma, exposed mesh with green bilious succus, frozen abdomen, inflammation, granulation tissue, purulent fluid collection, mesh eroded into small bowel, abscess, bacterial infection, serosanguineous drainage, abdominal wound, foreign body reaction, fever, and recurrence.Post-operative patient treatment included removal of mesh, splenectomy, small bowel resection, wound vac placement, evacuation of seroma, primary wound closure, incision and drainage of abscess, antibiotics, adhesiolysis, splenectomy, tacks removed, hospitalization, catheter, and repair of small bowel enterotomies.

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 the overlay implant, the patient experienced infected mesh, splenic laceration, adhesions, fistula, seroma, exposed mesh with green bilious succus, frozen abdomen, inflammation, granulation tissue, purulent fluid collection, mesh eroded into small bowel, abscess, bacterial infection, serosanguineous drainage, abdominal wound, foreign body reaction, fever, small bowel obstruction and recurrence.Post-operative patient treatment included removal of mesh, splenectomy, small bowel resection, wound vac placement, evacuation of seroma, primary wound closure, incision and drainage of abscess, antibiotics, adhesiolysis, splenectomy, tacks removed, hospitalization, catheter, and repair of small bowel enterotomies.

Manufacturer Narrative

Additional info: b5, b7, g1, g3, h6 (added patient codes, ime e2402: "frozen abdomen, allergic reaction").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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 the overlay implant, the patient experienced pain, allergic reaction, bleeding, perforation, infected mesh, splenic laceration, adhesions, fistula, seroma, exposed mesh with green bilious succus, frozen abdomen, inflammation, granulation tissue, purulent fluid collection, mesh eroded into small bowel, abscess, bacterial infection, serosanguineous drainage, abdominal wound, foreign body reaction, fever, small bowel obstruction and recurrence.Post-operative patient treatment included removal of mesh, antibiotics for 14+ days, removal of mesh, splenectomy, small bowel resection, wound vac placement, evacuation of seroma, primary wound closure, incision and drainage of abscess, antibiotics, adhesiolysis, splenectomy, tacks removed, hospitalization, catheter, and repair of small bowel enterotomies.

Manufacturer Narrative

Additional information: a4, a5b.(patient race), b5, b6, b7, h6 (added patient and imf codes).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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 the overlay implant, the patient experienced pain, allergic reaction, bleeding, perforation, infected mesh, splenic laceration, adhesions, fistula, seroma, exposed mesh with green bilious succus, frozen abdomen, inflammation, granulation tissue, purulent fluid collection, mesh eroded into small bowel, abscess, bacterial infection, serosanguineous drainage, abdominal wound, foreign body reaction, fever, small bowel obstruction, extraluminal air and trace fluid seen between loops of bowel trackingto the anterior midline, necrosis, fibrinopurulent exudate, and recurrence.Post-operative patient treatment included removal of mesh, antibiotics for 14+ days, removal of mesh, splenectomy, small bowel resection, wound vac placement, evacuation of seroma, primary wound closure, incision and drainage of abscess, adhesiolysis, splenectomy, tacks removed, hospitalization, catheter, ct scan, and repair of small bowel enterotomies.

• Brand Name: PARIETEX
• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 11855401
• MDR Text Key: 251689152
• Report Number: 9615742-2021-01300
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179745
• UDI-Public: 10884521179745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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,Followup,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: PRB1981X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2022
• Date Device Manufactured: 02/25/2017
• 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; Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White