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

Model Number	PCO9FX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the laparoscopic abdominal wall scar hernia surgery, nine years after the initial surgery, a second look at the repaired area revealed white dissemination on the abdominal wall where the mesh was placed.It was noted that the sizes of the lesion were 10mm x 15mm.And 10mm.
Additional Manufacturer Narrative
D10 concomitant products: pco1510fx, pco1510fx parietex pcox thr 15x10cmx1 (lot#:unknown).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
Additional information: d4(expiration date, lot#), g3, h3, h4, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but sixteen photos were available for evaluation.The evaluation found no potentially contributing factors.It was reported that there was a damage surrounding the anatomy.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.

• Brand Name: PARIETEX
• 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: 19937372
• Report Number: 9615742-2024-01127
• Device Sequence Number: 17362347
• Product Code: FTL
• UDI-Device Identifier: 10884521179868
• UDI-Public: 10884521179868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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 Expiration Date: 01/31/2019
• Device Model Number: PCO9FX
• Device Catalogue Number: PCO9FX
• Device Lot Number: POA1016X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2014
• 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 Sex: Female