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

Model Number TEM1509G

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Cyst(s) (1800); Emotional Changes (1831); Hematoma (1884); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Hernia (2240); Distress (2329); Discomfort (2330); Ascites (2596); Fibrosis (3167); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced pain, suffering, emotional distress, diminished quality of life, mental pain, adhesions, mesh migration, mesh had ballooned out through a recurrent hernia, inflammatory responses, discomfort, mental anguish, disability, device defective, permanent impairment, & loss of enjoyment of life.Post-operative patient treatment included revision surgery.

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

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced seroma, swelling, hematoma, nausea, vomiting, 360 cc of fluid aspirated from epigastric area, bowel problems, emotional problems, exposure, extrusion or protrusion, nerve damage, pain, suffering, emotional distress, diminished quality of life, mental pain, adhesions, mesh migration, mesh had ballooned out through a recurrent hernia, inflammatory responses, discomfort, mental anguish, disability, device defective, permanent impairment, loss of enjoyment of life.Post-operative patient treatment included revision surgery and excision of hematoma cavity of abdominal wall.

Manufacturer Narrative

Additional info: a1, a2 (date of birth), d4 (expiration date, lot#, udi#), h6 (patient codes).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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced abdominal wall mass, central portion filled with organizing fibrinous debris and red cells, fibrosis, cyst, abdominal pain, seroma, swelling, hematoma, nausea, vomiting, 360 cc of fluid aspirated from epigastric area, bowel problems, emotional problems, exposure, extrusion or protrusion, nerve damage, pain, suffering, emotional distress, diminished quality of life, mental pain, adhesions, mesh migration, mesh had ballooned out through a recurrent hernia, inflammatory responses, discomfort, mental anguish, disability, device defective, permanent impairment, loss of enjoyment of life.Post-operative patient treatment included aspiration of blood-tinged fluid, revision surgery, hernia repair with new mesh, and excision of hematoma cavity of abdominal wall.

Manufacturer Narrative

Additional info: h6 (patient codes, ime e2402: "mass").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.

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

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced abdominal wall mass, central portion filled with organizing fibrinous debris and red cells, fibrosis, cyst, abdominal pain, seroma, swelling, hematoma, nausea, vomiting, 360 cc of fluid aspirated from epigastric area, bowel problems, emotional problems, exposure, extrusion or protrusion, nerve damage, pain, suffering, emotional distress, diminished quality of life, mental pain, adhesions, mesh migration, mesh had ballooned out through a recurrent hernia, inflammatory responses, discomfort, mental anguish, disability, device defective, permanent impairment, scarring, ascites, and loss of enjoyment of life.Post-operative patient treatment included aspiration of blood-tinged fluid, revision surgery, hernia repair with n ew mesh, mesh revision, and excision of hematoma cavity of abdominal wall.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15492142
• MDR Text Key: 300636912
• Report Number: 9615742-2022-00861
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177673
• UDI-Public: 10884521177673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: TEM1509G
• Device Catalogue Number: TEM1509G
• Device Lot Number: SNH0629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• Date Device Manufactured: 09/04/2013
• 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): Required Intervention; Disability
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American