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

Model Number UNKNOWN PARIETEX PRODUCT

Device Problems Migration or Expulsion of Device (1395); 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); Dehydration (1807); Diarrhea (1811); Purulent Discharge (1812); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Seroma (2069); Skin Discoloration (2074); Vomiting (2144); Hernia (2240); Distress (2329); Discomfort (2330); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); 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 an incisional hernia.It was reported that after the preperitoneal implant, the patient experienced wound infection, open wound, adhesions, necrotic fascia, foul-smelling wound, mesh no incorporated, wound dehiscence, hematoma, serosal tear, fascia/external oblique on right gave way, recurrence, and free mesh.Post-operative patient treatment included revision surgery, debridement of wound, laparotomy, removal of mesh/spiral tacking metallic tackers, primary fascial closure, wound vac, left subclavian vein central line, necrotic fascia and pds sutures debrided, abdominal washout of old hematoma, debridement of fascial edges, closure of wound dehiscence, mesh reinforcement, two units of blood transfused for low preoperative hemoglobin, serosal repair with sutures, deeply fused viscera taken down, component separation attempted but abandoned, and wound irrigation.

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 an incisional hernia.It was reported that after the preperitoneal implant, the patient experienced wound infection, open wound, adhesions, necrotic fascia, foul-smelling wound, mesh no incorporated, wound dehiscence, hematoma, serosal tear, fascia/external oblique on right gave way, recurrence, pain, inability to exercise, walk with a cane, and free mesh.Post-operative patient treatment included revision surgery, debridement of wound, laparotomy, removal of mesh/spiral tacking metallic tackers, primary fascial closure, wound vac, left subclavian vein central line, necrotic fascia and pds sutures debrided, abdominal washout of old hematoma, debridement of fascial edges, closure of wound dehiscence, mesh reinforcement, two units of blood transfused for low preoperative hemoglobin, serosal repair with sutures, deeply fused viscera taken down, component separation attempted but abandoned, medication, hernia repair with mesh, and wound irrigation.

Manufacturer Narrative

Additional information: a4, a5, b2, b5, b6, b7, h6 (added patient and imf codes) ime 2402: foci of gas, lesion, colitis, fascia desiccated/macerated 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 incisional hernia.It was reported that after the preperitoneal implant, the patient experienced wound infection, open wound, adhesions, necrotic fascia, foul-smelling wound, mesh no incorporated, wound dehiscence, hematoma, serosal tear, fascia/external oblique on right gave way, recurrence, pain, inability to exercise, walk with a cane, foci of gas, seroma, abscess, bacterial infection, fluid collection, lobular heterogenous hyperdense lesion, colitis, attenuation, abdominal pain, nausea, fever, discoloration of skin, fascia desiccated/macerated, cellulitis, dehydrated, tenderness, diarrhea, vomiting, bloody drainage, drainage, open wound, and free mesh.Post-operative patient treatment included revision surgery, debridement of wound, laparotomy, removal of mesh/spiral tacking metallic tackers, primary fascial closure, wound vac, left subclavian vein central line, necrotic fascia and pds sutures debrided, abdominal washout of old hematoma, debridement of fascial edges, closure of wound dehiscence, mesh reinforcement, two units of blood transfused for low preoperative hemoglobin, serosal repair with sutures, deeply fused viscera taken down, component separation attempted but abandoned, medication, hernia repair with mesh, ct scan, admission to hospital, pca pump, wound packed, drainage of abscess, fluid aspirate d, picc line placed, and wound irrigation.

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 an incisional hernia.It was reported that after the preperitoneal implant, the patient experienced wound infection, open wound, adhesions, necrotic fascia, foul-smelling wound, mesh no incorporated, wound dehiscence, hematoma, serosal tear, fascia/external oblique on right gave way, recurrence, pain, inability to exercise, walk with a cane, foci of gas, seroma, abscess, bacterial infection, fluid collection, lobular heterogenous hyperdense lesion, colitis, attenuation, abdominal pain, nausea, fever, discoloration of skin, fascia desiccated/macerated, cellulitis, dehydrated, tenderness, diarrhea, vomiting, bloody drainage, drainage, open wound, free mesh, & emotional distress.Post-operative patient treatment included revision surgery, debridement of wound, laparotomy, removal of mesh/spiral tacking metallic tackers, primary fascial closure, wound vac, left subclavian vein central line, necrotic fascia and pds sutures debrided, abdominal washout of old hematoma, debridement of fascial edges, closure of wound dehiscence, mesh reinforcement, two units of blood transfused for low preoperative hemoglobin, serosal repair with sutures, deeply fused viscera taken down, component separation attempted but abandoned, medication, hernia repair with mesh, ct scan, admission to hospital, pca pump, wound packed, drainage of abscess, fluid aspirated, picc line placed, and wound irrigation.

• Brand Name: 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 9883708
• MDR Text Key: 185902372
• Report Number: 9615742-2020-00646
• 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,Followup,Followup
• Report Date: 04/18/2023

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 Model Number: UNKNOWN PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 08/17/2022; 11/16/2022; 04/12/2023
• Supplement Dates FDA Received: 08/24/2022; 12/13/2022; 04/18/2023
• 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: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American