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

Model Number TMP2008G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Shock (2072)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, based on clinical study, a patient who undergone posterior pelvectomy for synchronous rectal and uterine cancer, had suffered from wall hematoma and hemorrhagic shock on retromuscular bleeding at the prosthesis level was assessed and might be related to the mesh rather than the procedure.Reason for mesh removal; hypovolemic shock due to active bleeding of inferior epigastric vessels, the mesh was removed because a reintervention was required and thus, a risk of mesh infection would be increased.Cbc, ct-scan, and bacterial culture were done to the patient.The mesh was removed on (b)(6) 2021.This caused extended hospital stay for 10 days.The patient was also treated with blood transfusion of 7 units and plasma 3x.Patient's surgical history include de-functioning colostomy/laparotomy.Patient's co-morbidities include hypercholesterolemia, epilepsy and atrial fibrillation (requiring anticoagulation).

Event Description

According to the reporter, based on clinical study, a patient who undergone posterior pelvectomy for synchronous rectal and uterine cancer, had suffered from wall hematoma and hemorrhagic shock on retromuscular bleeding at the prosthesis level was assessed and might be related to the mesh rather than the procedure.Reason for mesh removal; hypovolemic shock due to active bleeding of inferior epigastric vessels, the mesh was removed because a reintervention was required and thus, a risk of mesh infection would be increased.Cbc, ct-scan, and bacterial culture were done to the patient.The mesh was removed on (b)(6) 2021.The patient was also treated with blood transfusion of 7 units and plasma 3x.Patient's surgical history include de-functioning colostomy/laparotomy.Patient's co-morbidities include hypercholesterolemia, epilepsy and atrial fibrillation (requiring anticoagulation).

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.

• Brand Name: PROGRIP
• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 11688530
• MDR Text Key: 246225780
• Report Number: 9615742-2021-00863
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TMP2008G
• Device Catalogue Number: TMP2008G
• Device Lot Number: SUH0249X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Date Device Manufactured: 08/13/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Female