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

Model Number	TSB1510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
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, post-operatively, the patient presented after one year for a scheduled follow up and reported that they had a recent coughing attack and felt a worm-like protrusion in their upper abdomen.The patient felt the sensation when abdominal muscles were contracting with coughing, laughing, or sneezing.A diagnostic ultrasound performed on (b)(6) 2025 showed fat containing supraumbilical ventral hernia.The patient had a ventral hernia recurrence.The investigator and sponsor assessed that the adverse event was not related to an outside standard of care cip procedure but has causal relationship to the study procedure and the study mesh.
Additional Manufacturer Narrative
Additional information: b5, g3.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, post-operatively, the patient presented after one year for a scheduled follow up and reported that they had a recent coughing attack and felt a worm-like protrusion in their upper abdomen.The patient felt the sensation when abdominal muscles were contracting with coughing, laughing, or sneezing.A diagnostic ultrasound performed on (b)(6) 2025 showed fat containing supraumbilical ventral hernia.The patient had a ventral hernia recurrence.The sponsor assessed that the adverse event was not related to an outside standard of care cip procedure and the study mesh, but has causal relationship to the study procedure.On the other hand, the investigator assessed that the adverse event was not related to an outside standard of care cip procedure, but has causal relationship to the study procedure and the study mesh.
Additional Manufacturer Narrative
Additional information: b5, g3 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, post-operatively, the patient presented after one year for a scheduled follow up and reported that they had a recent coughing attack and felt a worm-like protrusion in their upper abdomen.The patient felt the sensation when abdominal muscles were contracting with coughing, laughing, or sneezing.A diagnostic ultrasound performed on (b)(6)2025 showed fat containing supraumbilical ventral hernia.The patient had a ventral hernia recurrence.The sponsor assessed that that the adverse event was not related to an outside standard of care cip procedure and the study mesh, but has causal relationship to the study procedure.The site assessed that the adverse event is not related to the study procedure nor the study mesh.On the other hand, the investigator assessed that the adverse event was not related to an outside standard of care cip procedure, but has causal relationship to the study procedure and the study 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: 23346884
• Report Number: 9615742-2025-01200
• Device Sequence Number: 18085318
• Product Code: OWT
• UDI-Device Identifier: 10884521809703
• UDI-Public: (01)10884521809703(17)270131(10)SYB0654X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: TSB1510
• Device Catalogue Number: TSB1510
• Device Lot Number: SYB0654X
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 03/05/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/26/2026; 03/13/2026
• Date Device Manufactured: 02/08/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White