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

Model Number	DXT1510AR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
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 reporter, post-operatively, the patient had hernia recurrence; the patient felt the mesh split and hernia popping out after coughing 32 weeks from the operation.Adverse event resulted in hospitalization. it was noted that the patient was managing pain with regular analgesia.Symptomatic right inguinal hernia, reducible, that did not extend into the scrotum, less than 3cm, l2 right indirect inguinal hernia.The mesh was placed flat widely covering all hernia defects anterior to peritoneum on both sides, tucked behind pubis.
Additional Manufacturer Narrative
Additional information: b5, h3 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, post-operatively, of a primary repair of inguinal hernia using insert prosthetic material, the patient had hernia recurrence; the patient felt the mesh split and hernia popping out after coughing 32 weeks from the operation.Adverse event resulted in hospitalization.It was noted that the patient was managing pain with regular analgesia.Symptomatic right inguinal hernia, reducible, that did not extend into the scrotum, less than 3cm, l2 right indirect inguinal hernia.The mesh was placed flat widely covering all hernia defects anterior to peritoneum on both sides, tucked behind pubis.

• 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: 19042779
• Report Number: 9615742-2024-00493
• Device Sequence Number: 12573333
• Product Code: FTL
• UDI-Device Identifier: 10884521726512
• UDI-Public: 10884521726512
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DXT1510AR
• Device Catalogue Number: DXT1510AR
• Device Lot Number: SXE1298X
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male