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

Model Number	TET2020
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Bacterial Infection (1735); Cellulitis (1768); Diarrhea (1811); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness/Atrophy (1967); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Anxiety (2328); Impaired Healing (2378); Ambulation or Postural Difficulties (2544); Ascites (2596); Abdominal Distention (2601); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: lsi solutions inc- dev ti-knot quick load-log1467200, product id: 030510, lot # 588554, bard peripheral vascu- 4x4 flt surg cvs ptfe-log1467200, product id: 007836, lot # hubq2265.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a abdominal hernia.It was reported that after implant, the patient experienced mesh design defect.Post-operative patient treatment included a revision surgery.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an abdominal hernia.It was reported that after implant, the patient experienced abdominal wall necrosis.Post-operative patient treatment included a revision surgery and mesh removal.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an abdominal hernia.It was reported that after implant, the patient experienced pain, infection, perforation, inflammation, diarrhea, difficulty ambulating, abdominal wall necrosis.Post-operative patient treatment included a revision surgery, medication, debridement of skin, excision of abdominal wall, and mesh removal.Concomitant devices: lsi solutions inc- dev ti-knot quick load-log1467200, product id 030510, lot # 588554 bard peripheral vascu- 4x4 flt surg cvs ptfe-log1467200, porduct id 007836, lot # hubq2265.
Additional Manufacturer Narrative
Additional information: a4, b5, b7, g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6(patient codes, device codes), additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an ventral hernia.It was reported that after implant, the patient experienced pain, infection, perforation, inflammation, diarrhea, difficulty ambulating, abdominal wall necrosis, labs abnormal for hemoglobin; hematocrit, bacterial infections, fluid collection, seroma, hematoma, staph, scarring, physical deconditioning, decreased functional mobility, weakness, pain with activity, nausea, vomiting, anxiety, wound dehiscence, blood supply loss, mesh not fully integrated, ascites, lump, abdominal pain, edema, wound cellulitis, abdominal distention, open wound of abdominal wall.Post-operative patient treatment included a revision surgery, medication, debridement of skin, excision of abdominal wall, mesh removal, ultrasound, ct guided drain placement, pca, short term rehabilitation facility, pt/ot, pain medication, anti-nausea medication, assistance with activities of daily living, oxygen supplementation, iv antibiotics, wound care, abdominal wall reconstruction, partial removal of mesh, tap block, iv fluids, negative pressure wound therapy.
Additional Manufacturer Narrative
H6 (patient codes, device codes, ime e2402: labs abnormal for hemoglobin; hem atocrit, physical deconditioning).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
• Common Device Name: 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, CT 55112 ; 7635265677
• MDR Report Key: 11791732
• Report Number: 9615742-2021-00995
• Device Sequence Number: 11726187
• Product Code: FTL
• UDI-Device Identifier: 10884521180352
• UDI-Public: 10884521180352
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: TET2020
• Device Catalogue Number: TET2020
• Device Lot Number: SRA1808X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 05/17/2023; 01/24/2024
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 11/12/2021; 05/18/2023; 02/13/2024
• Date Device Manufactured: 01/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White