MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS TSB2020 SLF GRIPPING RESORB MESH 20X20CM; MESH, SURGICAL, ABSORBABLE, ABDOMINAL HERNIA

Model Number	TSB2020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction

• Brand Name: TSB2020 SLF GRIPPING RESORB MESH 20X20CM
• 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 ; +1(800)646-4633
• MDR Report Key: 50829159
• Report Number: 9615742-2026-00830
• Device Sequence Number: 8644542
• Product Code: OWT
• UDI-Device Identifier: 10884521809710
• UDI-Public: (01)10884521809710(17)270731(10)SYH2195X(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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: TSB2020
• Device Catalogue Number: TSB2020
• Device Lot Number: SYH2195X
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 08/22/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 234 LB
• Patient Race: White