MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS TRANSORB; MESH, SURGICAL, ABSORBABLE, ABDOMINAL HERNIA

Model Number	TSB3030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Necrosis (1971); Obstruction/Occlusion (2422); Unintended Radiation Exposure (4565); Insufficient Information (4580)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the clinical study, two days post-operatively, the patient would not resume transit with the need to maintain a nasogastric tube.Five days later, x-ray was performed and it was noted that the patient had small intestinal obstruction.To resolve the issue.The patient underwent exploratory laparoscopy to explant the study mesh and replace it with a new one.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 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 or Problem Description
According to the clinical study, two days post-operatively, the patient would not resume transit with the need to maintain a nasogastric tube.Five days later, x-ray was performed and it was noted that the patient had small intestinal obstruction.To resolve the issue., the patient underwent exploratory laparoscopy to explant the study mesh and replace it with a new one.It was noted that while retaining the study mesh, there was a 20 cm necrosis.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (imf f1903 removed) 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 or Problem Description
According to the clinical study, two days post-operatively, the patient would not resume transit with the need to maintain a nasogastric tube.Five days later, x-ray was performed and it was noted that the patient had mechanical small intestinal obstruction.To resolve the issue, the patient underwent exploratory laparoscopy without cutting the mesh and an intraperitoneal biological mesh was placed, while retaining the initial study mesh.It was noted that while retaining the study mesh, there was a 20 centimeter necrosis.
Event or Problem Description
According to the clinical study, two days post-operatively, the patient would not resume transit with the need to maintain a nasogastric tube.Five days later, x-ray was performed and it was noted that the patient had mechanical small intestinal obstruction.To resolve the issue, the patient underwent exploratory laparoscopy without cutting the mesh and an intraperitoneal biological mesh was placed, while retaining the initial study mesh.It was noted that while retaining the study mesh, there was a 20 centimeter necrosis.Per sponsor assessment, the adverse events are possibly related to the index procedure and not related to the study mesh nor the outside standard of care cip procedure.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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: TRANSORB
• Common Device Name: MESH, SURGICAL, ABSORBABLE, ABDOMINAL HERNIA
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 21249470
• Report Number: 9615742-2025-00084
• Device Sequence Number: 8056259
• Product Code: OWT
• UDI-Device Identifier: 10884521809727
• UDI-Public: 10884521809727
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K233661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: TSB3030
• Device Catalogue Number: TSB3030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 07/29/2025; 12/11/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 06/24/2025; 08/05/2025; 12/18/2025
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 63 KG