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

Model Number UNKNOWN SYMBOTEX MESH

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Hernia (2240); Paresthesia (4421); Unspecified Tissue Injury (4559)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unksymbotex - unknown symbotex mesh, lot#: unknown.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, postoperative to implantation of intraperitoneal mesh fused to small bowel, which were placed on two separate occasions, the patient developed a symptomatic recurrent incisional hernia after the last implantation.The symptoms included severe pain and functional disability.At the time of explantation, the previous meshes were found to be fused to a portion of her small intestine requiring bowel resection as well as complete mesh explantation.The patient underwent a complex operation and had a complicated postoperative course.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, postoperative to implantation of intraperitoneal mesh fused to small bowel, which were placed on two separate occasions, the patient developed a symptomatic recurrent incisional hernia after the last implantation.The symptoms included severe pain and functional disability.At the time of explantation, the previous meshes were found to be fused to a portion of her small intestine requiring bowel resection as well as complete mesh explantation.It was also noted that the patient had paresthesia and failure of implant.The patient underwent a complex operation and had a complicated postoperative course due to the mesh fused and recurrence.

• Brand Name: UNKNOWN SYMBOTEX MESH
• Type of Device: 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: 15704494
• MDR Text Key: 302765430
• Report Number: 9615742-2022-01026
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SYMBOTEX MESH
• Device Catalogue Number: UNKNOWN SYMBOTEX MESH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization; Disability