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

Model Number	TEC3030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Fever (1858); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); Foreign Body In Patient (2687); No Code Available (3191); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 recurrent incarcerated incisional hernia.It was reported that after implant, the patient experienced adhesions to bowel, abscess, seroma formation, wound infection with infected mesh.Post-operative patient treatment included revision surgery.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent incarcerated incisional hernia.It was reported that after implant, the patient experienced adhesions, abscess, seroma formation, wound infection with infected mesh, draining open wound, intra-abdominal abscesses, dehiscence of subcutaneous tissues, infected foreign body, scarring, fistula, sinus tract, drainage, induration, cellulitis, hematoma, inflammation, necrosis, abdominal pain, fever, nausea, emesis, purulent material, recurrence, and pus looking like fluid.Post-operative patient treatment included revision surgery, debridement of soft tissue, split thickness skin graft to close wound, wound vac, admitted to hospital/icu, removal of mesh, antibiotics, necrotic tissue excised, irrigation, hernia repair with mesh, debridement of necrotic and infected anterior abdominal wall fascia, resection of antimesenteric border of two pieces of intestine, closure of wound, and explant of infected mesh.
Additional Manufacturer Narrative
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 recurrent incarcerated incisional hernia.It was reported that after implant, the patient experienced adhesions to bowel, abscess, seroma formation, wound infection with infected mesh, draining wound, intra-abdominal abscesses, dehiscence of subcutaneous tissues, infected foreign body, scarring and pus looking like fluid.Post-operative patient treatment included revision surgery, debridement of soft tissue, and partial explant of infected mesh.The device had been used with unknown protack.
Additional Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt. due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 recurrent incarcerated incisional hernia.It was reported that after implant, the patient experienced adhesions to bowel, abscess, seroma formation, wound infection with infected mesh, draining wound, intra-abdominal abscesses, dehiscence of subcutaneous tissues, debridement of soft tissue, infected foreign body, scarring and pus looking like fluid.Post-operative patient treatment included revision surgery.The device had been used with unknown protack.
Additional Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.If information is provided in the future, a supplemental report will be issued.
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 a recurrent incarcerated incisional hernia.It was reported that after implant, the patient experienced pain, adhesions, abscess, seroma formation, wound infection with infected mesh, draining open wound, intra-abdominal abscesses, dehiscence of subcutaneous tissues, infected foreign body, scarring, fistula, sinus tract, drainage, induration, cellulitis, hematoma, inflammation, necrosis, abdominal pain, fever, nausea, emesis, purulent material, recurrence, and pus looking like fluid.Post-operative patient treatment included revision surgery, debridement of soft tissue, split thickness skin graft to close wound, wound vac, admitted to hospital/icu, removal of mesh, antibiotics, necrotic tissue excised, irrigation, hernia repair with mesh, debridement of necrotic and infected anterior abdominal wall fascia, resection of antimesenteric border of two pieces of intestine, closure of wound, partial explant of mesh, ct-scan, and explant of infected mesh.Relevant tests/laboratory data, including dates (b7): (b)(6) 2018: ct scan of abdomen/pelvis showed ventral lower abdominal to upper pelvic hernia mesh with moderate stranding and induration with low attenuating ill-defined areas in the extra abdominal deep superficial soft tissues.Patient suffers cutaneous draining wound; therefore, findings highly suspicious for infected mesh.Localized mass collections suspicious for intra-abdominal abscesses.(b)(6) 2018: ct of chest, abdomen and pelvis showed interval dehiscence of subcutaneous tissues periumbilical and supraumbilical midline.Fat stranding and left greater than right skin thickening raised possibility of infection/cellulitis.Anterior abdominal collection may represent hematoma/seroma or abscess.(b)(6) 2018: pathology report for foreign body mesh showed mesh identified.Skin and soft tissue showed severe and chronic inflammation with soft tissue necrosis.(b)(6) 2019: pathology report from mesh specimens showed acute and chronic inflammation.
Additional Manufacturer Narrative
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.

• 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8145172
• Report Number: 9615742-2018-02726
• Device Sequence Number: 19399605
• Product Code: FTL
• UDI-Device Identifier: 10884521180031
• UDI-Public: 10884521180031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/30/2024

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: 04/30/2020
• Device Model Number: TEC3030
• Device Catalogue Number: TEC3030
• Device Lot Number: SPD0753X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019; 03/18/2020; 01/18/2023; 07/24/2024
• Initial Report FDA Received Date: 12/09/2018
• Supplement Report FDA Received Date: 10/03/2019; 10/22/2019; 04/06/2020; 01/23/2023; 07/30/2024
• Date Device Manufactured: 05/12/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PROTACK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White