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

Model Number TEM3015G

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/23/2022

Event Type  Injury  

Event Description

According to the reporter, post operatively, on an open hernia rectus diastasis procedure, the primary surgery was performed as planned.The mesh was cut prior to implantation.The problem was that the mesh was wrecked by 30 cm after insertion into the patient.The wound was closed with sutures after the procedure.It was noted the patient had to come back for a re-operation to resolve the issue and was hospitalized.

Manufacturer Narrative

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

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, post-operative of a ventral hernia, the primary surgery was performed as planned.There was a big ventral hernia with the patient's small intestine, and colon outside of the body.The mesh was placed in a sub lay technique, but could not completely close the anterior rectus fascia, so the user had to suture approximately 5 cm of the tissue into the mesh.It was noted the patient used a girdle.After a few days, the patient experienced difficulties in breathing.As the intestines were put back into the abdomen, the operator understood that the patient¿s breathing problems could be due to a high intra-abdominal pressure which was 16 at that time.The surgeon decided to do a re-surgery and discovered that the mesh was completely broken into two pieces from cranially to caudal.The doctor removed one half of the mesh.The other part was already in growth.A big mesh of 30x30 cm from another company was then placed and a vacuum system was put on the wound.

Event Description

According to the reporter, post operative a ventral hernia, the primary surgery was performed as planned.There was a big ventral hernia with the patients small intestine and colon outside the body of the patient.The mesh was placed in a sub lay technique, but he could not completely close the anterior rectus fascia, so he had to suture approx.5 cm of the anterior rectus fascia into the mesh.The patient used a girdle.After a few days the patient experienced difficulties in breathing.As the intestine were put back into the abdomen, he understood that her breathing problem could be due to a high intra-abdominal pressure.The abdominal pressure was at that time 16.Surgeon decided to do a re-surgery.During re-surgery he discovered that the mesh was completely broken into two pieces from cranially to caudal.He removed one half of the mesh.The other part was already ingrowth.He then placed a big mesh 30x30 cm from another company on lay and put a vac-system on the wound.

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 80301 ; 3035816943
• MDR Report Key: 14136010
• MDR Text Key: 289443914
• Report Number: 9615742-2022-00330
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177741
• UDI-Public: 10884521177741
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: TEM3015G
• Device Catalogue Number: TEM3015G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female