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

Model Number PCO6VP

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Vomiting (2144); Electrolyte Imbalance (2196); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced adhesions, recurrence, dilated fluid-filled small bowel loops, free air, ascites, attenuation, inflammation, diastases, tenderness, abdominal pain, pain, ileus, erythema, distention, turbid fluid, enterotomy, frozen abdomen, serosal tear, perforation, edematous, vomiting of green fluid, nausea, necrosis, purulent material, and small bowel obstruction.Post-operative patient treatment included revision surgery, mesh removal, steroid injections, admission to hospital, medication, antibiotics, small bowel resection, wound vac, serosal tears repaired, perforation site closed, tpn, and lysis of adhesions.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced defective device, mental pain, permanent impairment, loss of enjoyment of life, scarring discomfort, adhesions, recurrence, dilated fluid-filled small bowel loops, free air, ascites, attenuation, inflammation, diastases, tenderness, abdominal pain, pain, ileus, erythema, distention, turbid fluid, enterotomy, frozen abdomen, serosal tear, perforation, edematous, vomiting of green fluid, nausea, necrosis, purulent material, and small bowel obstruction.Post-operative patient treatment included revision surgery, mesh removal, steroid injections, admission to hospital, medication, antibiotics, small bowel resection, wound vac, serosal tears repaired, perforation site closed, tpn, and lysis of adhesions.

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.

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.

Manufacturer Narrative

Additional information: a4, b5, b7, g1, h4, h6 (ime, imf, ime e2402: labs abnormal for wbc 19.2; hemoglobin 11.4; hematocrit 34.1; platelets 656; ast 64; alt 183, labs abnormal for alkaline phos 207; albumin 3.3).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 an umbilical hernia.It was reported that after implant, the patient experienced defective device, mental pain, permanent impairment, loss of enjoyment of life, scarring, discomfort, adhesions, recurrence, dilated fluid-filled small bowel loops, free air, ascites, attenuation, inflammation, diastasis, tenderness, abdominal pain, pain, ileus, erythema, distention, turbid fluid, enterotomy, frozen abdomen, serosal tear, perforation, edematous, vomiting of green fluid, nausea, necrosis, purulent material, small bowel obstruction, labs abnormal for wbc 19.2; hemoglobin 11.4; hematocrit 34.1; platelets 656; sodium 131; glucose 126; chloride 97; ast 64; alt 183; alkaline phos 207; albumin 3.3.Post-operative patient treatment included revision surgery, mesh removal, steroid injections, admission to hospital, medication, antibiotics, small bowel resection, wound vac, serosal tears repaired, ct scan, perforation site closed, tpn, lysis of adhesions, hernia repair with mesh.

• 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: 12285380
• MDR Text Key: 265354508
• Report Number: 9615742-2021-01899
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521514157
• UDI-Public: 10884521514157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PNC0035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2024
• Date Device Manufactured: 03/19/2013
• 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; Disability
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White