MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS DEXTILE; MESH, SURGICAL, POLYMERIC

Model Number	DXT1309AR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Laceration(s) (1946); Hernia (2240); Swelling/ Edema (4577)
Date of Event	07/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: dxt1309al, dextile dxt1309al 13x9cm left x1 (lot#: sub0165x).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, following a laparoscopic totally extraperitoneal left inguinal hernia repair procedure, the patient had a swollen left groin; the same side of the procedure.It was concluded that the patient had an inguinal hernia recurrence after an anamnesis and physical examination was performed.To resolve the issue, the patient had to undergo a lichtenstein procedure.It was noted that the patient's oxygen saturation (spo2) was 97%.The patient has recovered.

• Brand Name: DEXTILE
• Common Device Name: MESH, SURGICAL, POLYMERIC
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20225802
• Report Number: 9615742-2024-01317
• Device Sequence Number: 7174890
• Product Code: FTL
• UDI-Device Identifier: 10884521726499
• UDI-Public: 10884521726499
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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 Expiration Date: 11/30/2025
• Device Model Number: DXT1309AR
• Device Catalogue Number: DXT1309AR
• Device Lot Number: SUL1336X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 12/23/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG