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	Hematoma (1884); Inflammation (1932); Scar Tissue (2060); Seroma (2069); Unintended Radiation Exposure (4565); Swelling/ Edema (4577)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the implantation of the mesh, there was a subcutaneous seroma, swelling at the site of the former hernia without pain, inflammation with pus in the pelvic area, a hard but painless left abdomen, and a scar with staples in the periumbilical/pelvic area.Diagnostic tests included physical examination, tap scanner imaging, and liquid puncture for the seroma.Interventions performed were liquid puncture and the introduction or restart of anticoagulants after surgery.A liquid puncture was performed for the seroma, and anticoagulants were introduced or restarted after surgery on (b)(6) 2025.The adverse event was resolved.Both the investigator and sponsor assessed the event as possibly related to the index procedure and the study mesh.
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
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
It was reported that 14 days following the implantation of the mesh, there was a subcutaneous seroma, swelling at the site of the former hernia without pain, inflammation with pus in the pelvic area, a hard but painless left abdomen, and a scar with staples in the periumbilical/pelvic area.Diagnostic tests included physical examination, tap scanner imaging, liquid puncture for the seroma, and clinical examination.Clinical examination showed that there was less than a centimeter of disunion at the umbilical level that was healing.Interventions performed were liquid puncture and the introduction or restart of anticoagulants after surgery.A liquid puncture was performed for the seroma, and anticoagulants were introduced or restarted after surgery on (b)(6) 2025.The adverse events were resolved.Both the investigator and sponsor assessed the subcutaneous seroma was possibly related to the index procedure and the study mesh.The disunion of the scar was assessed by the investigator as possibly related to the index study procedure and the outside standard of care cip procedure.The sponsor assessed the disunion to be possibly related to the index study procedure and but not related to the outside standard of care cip procedure.Both sponsor and investigator assessed that the disunion was not related to the study mesh.
Additional Manufacturer Narrative
Additional information: b5, g3 correction: h6 (removed fdp/ime code: c50579).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
It was reported that 14 days following the implantation of the mesh, there was a subcutaneous seroma, swelling at the site of the former hernia without pain, inflammation with pus in the pelvic area, a hard but painless left abdomen, and a scar with staples in the periumbilical/pelvic area.Diagnostic tests included physical examination, tap scanner imaging, liquid puncture for the seroma, and clinical examination.Clinical examination showed that there was less than a centimeter of disunion at the umbilical level that was healing.Interventions performed were liquid puncture and the introduction or restart of anticoagulants after surgery.A liquid puncture was performed for the seroma, and anticoagulants were introduced or restarted after surgery on (b)(6) 2025.The adverse events were resolved.Both the investigator and sponsor assessed the subcutaneous seroma was possibly related to the index procedure and the study mesh.The disunion of the scar was assessed by the investigator as possibly related to the index study procedure and the outside standard of care cip procedure.The sponsor assessed the disunion to be possibly related to the index study procedure and but not related to the outside standard of care cip procedure.The adverse event was not related to the device but had possible relation the study procedure.

• 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--439 ; 8006464633
• MDR Report Key: 23080609
• Report Number: 9615742-2025-01100
• Device Sequence Number: 4644902
• Product Code: OWT
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2026

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 Model Number: TSB3030
• Device Catalogue Number: TSB3030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 09/22/2025; 09/08/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/02/2025; 10/02/2025; 09/11/2026
• 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: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female