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); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Fever (1858); Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Retention (2119); Vomiting (2144); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Sore Throat (2396); Fungal Infection (2419); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Weight Changes (2607); Fluid Discharge (2686); Constipation (3274); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 hernia.It was reported that after implant, the patient experienced infection, abscess, adhesions, obstruction, pain, hematoma, inflammation, scarification, mesh encapsulation, and lack of adequate ingrowth.Post-operative patient treatment included revision surgery.

Manufacturer Narrative

Additional info: a2 (date of birth), a4, b2, b5, b7, d6b, g1, g3, h6 (patient codes) h6 ime e2402: "mass" 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 an umbilical hernia.It was reported that after implant, the patient experienced impairment, abscess, drainage, infection, hematoma, pain, recurrence, inflammation, adhesions, obstruction, seroma, scarring, mesh encapsulation, tenderness, mass, lack of adequate ingrowth.Post-operative patient treatment included medication, revision surgery, partial removal of mesh, removal of mesh, diagnostic laparoscopy, drainage of abdominal wall abscess, small bowel enterolysis, debridement/drainage of suspected infected hematoma, excision of abdominal wall mass and fine needle aspiration.

Manufacturer Narrative

Additional info: e2402: elevated inr (international normalized ratio), firmness, induration, anorexia, mass, skin thickening, white blood cells/bandemia, elevated creatine kinase, firmness, lipoma) 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 laparoscopic therapeutic treatment of an incisional umbilical hernia.It was reported that after implant, the patient experienced skin thickening, staphylococcus aureus, purulent material, necrosis, fluid collection, elevated white blood cells/bandemia, elevated creatine kinase, elevated inr (international normalized ratio), tenderness, firmness, swelling, induration, lipoma, cellulitis, redness, fever, edema, mesh not fully incorporated, nausea, difficulty urinating, abdominal distention, constipation, anorexia, vomiting, abdominal pain, weight gain, impairment, abscess, drainage, infection, hematoma, pain, recurrence, inflammation, adhesions, obstruction, seroma, scarring, mesh encapsulation, tenderness, mass, and lack of adequate ingrowth.Post-operative patient treatment included ct scan, ultrasound, medication, antibiotics, pain medications, hospitalization, iv fluids, ct fine needle aspiration, medical weight loss program, revision surgery, partial removal of mesh, removal of mesh, diagnostic laparoscopy, drainage of abdominal wall abscess, small bowel enterolysis, debridement/drainage of suspected infected hematoma, excision of abdominal wall mass and fine needle aspiration.

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.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional umbilical hernia.It was reported that after implant, the patient experienced skin thickening, staphylococcus aureus, purulent material, necrosis, fluid collection, elevated white blood cells/bandemia, elevated creatine kinase, elevated inr (international normalized ratio), tenderness, firmness, swelling, induration, lipoma, cellulitis, redness, fever, edema, mesh not fully incorporated, nausea, difficulty urinating, abdominal distention, constipation, anorexia, vomiting, abdominal pain, weight gain, impairment, abscess, drainage, infection, hematoma, pain, recurrence, inflammation, adhesions, obstruction, seroma, scarring, mesh encapsulation, tenderness, mass, and lack of adequate ingrowth.Post-operative patient treatment included tap nerve block, ct scan, ultrasound, medication, antibiotics, pain medications, hospitalization, iv fluids, ct fine needle aspiration, medical weight loss program, revision surgery, partial removal of mesh, removal of mesh, diagnostic laparoscopy, drainage of abdominal wall abscess, small bowel enterolysis, debridement/drainage of suspected infected hematoma, excision of abdominal wall mass and fine needle aspiration.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional umbilical hernia.It was reported that after implant, the patient experienced skin thickening, staphylococcus aureus, purulent material, necrosis, fluid collection, elevated white blood cells/bandemia, elevated creatine kinase, elevated inr (international normalized ratio), tenderness, firmness, swelling, induration, lipoma, cellulitis, redness, fever, edema, mesh not fully incorporated, nausea, difficulty urinating, abdominal distention, constipation, anorexia, vomiting, abdominal pain, weight gain, impairment, abscess, drainage, infection, hematoma, pain, recurrence, inflammation, adhesions, obstruction, seroma, scarring, mesh encapsulation, tenderness, mass, lack of adequate ingrowth, dilation of small and large bowel loops, ileus, abnormal white blood count, sore throat white spots (fungal/yeast infection), weakness, decreased level of consciousness, small open wound, diastases.Post-operative patient treatment included tap nerve block, ct scan, ultrasound, medication, antibiotics, pain medications, hospitalization, iv fluids, ct fine needle aspiration, medical weight loss program, revision surgery, partial removal of mesh, removal of mesh, diagnostic laparoscopy, drainage of abdominal wall abscess, small bowel enterolysis, debridement/drainage of suspected infected hematoma, e xcision of abdominal wall mass, fine needle aspiration, abdominal x-ray, antifungal, ng decompression, hernia reduced, component separation, hernia repair with mesh.

Manufacturer Narrative

Ime e2402: ileus, abnormal white blood count, decreased level of consciousness).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.

• 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: 15075665
• MDR Text Key: 296315345
• Report Number: 9615742-2022-00634
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: PRG0080X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Date Device Manufactured: 07/18/2017
• 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; Disability; Required Intervention
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White