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

Model Number	TSB3030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Inflammation (1932); Tissue Breakdown (2681); Unintended Radiation Exposure (4565); Insufficient Information (4580)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during clinical, the patient had a chronic purulent wound.The wound was fibrinous, purulent, and oozing.Laboratory tests showed a crp level of 13 mg/l.A computed tomography scan revealed a subcutaneous infiltration without collection in contact with the prosthesis.Given the poor progress of the wound, the patient was taken to the operating room.Debridement and application of a vac-type dressing.The mesh is still implanted.The patient was hospitalized from (b)(6) 2025.The adverse event was related to the study mesh and procedure.
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.
Additional Manufacturer Narrative
Correction: b5, 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.
Event or Problem Description
According to the reporter, during clinical, the patient had a chronic purulent wound.The wound was fibrinous, purulent, and oozing.Laboratory tests showed a crp level of 13 mg/l.A computed tomography scan revealed a subcutaneous infiltration without collection in contact with the prosthesis.Given the poor progress of the wound, the patient was taken to the operating room.Debridement and application of a vac-type dressing.The mesh is still implanted.The patient was hospitalized from (b)(6) 2025, until (b)(6) 2025.The adverse event was related to the study procedure and not related to the mesh.

• 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: 23892319
• Report Number: 9615742-2025-01429
• Device Sequence Number: 5331125
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TSB3030
• Device Catalogue Number: TSB3030
• Device Lot Number: RXI1180X
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 03/23/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female