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

Model Number UNKNOWN PROGRIP MESH PRODUCT

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

Patient Problems Death (1802); Pain (1994)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient had reoccurring and repair to the right side, however, the patient felt severe pain on the left side.It was stated that the patient could not ride a car and feels pain when walking.

Event Description

According to the reporter, the patient had reoccurring and repair to the right side however, the patient felt severe pain on the left side following a bilateral inguinal hernia.It was stated that the patient could not ride a car and feels pain when walking.Pre-operatively, the patient presented with a symptomatic right inguinal hernia on ct scan.The patient also had a left inguinal hernia.The patient was aware of the risk, benefits and alternatives of the procedure including bleeding, infection, injury to adjacent structure, need for operation, vesical injury, vas deferens injury, chronic pain, post-operative swelling, bruising, and the possibility of recurrence.The patient understood and consented to the procedure.The patient understood that if the left side appeared to be herniated intra-operatively, it would be fixed as well.The patient was the taken to the operating room, placed in a supine position, underwent endotracheal anesthesia and was then placed in lithotomy.The patient had a catheter placed, prepped and draped in then usual fashion.The surgical pause completed.All parties were in agreement with the correct site, correct patient and correct procedure.They began making a 12 incision about 10cm above the umbilicus, carried down to the fascia, incisive the fascia, entered the abdominal cavity, placed the trocar and placed three 8mm trocars.It was stated that one trocar was placed in the right quadrant, one in the left upper quadrant, and the one in the left flank.The robot was hen docked and pelvis was examined.The patient had a large right-sided hernia and a left-sided hernia as week.The surgeon started with the right side, took down the peritoneum in the avascular plane, pulled it down, separated and examined the contents of the hernia sac.On the right side, a direct hernia was peeled of easily.The spermatic cord was examined.The patient had a large cord lipoma which was easily peeled off as well.Once the dissection was completed, they completely dissected out the direct and indirect hernia space as well as sparing the cord structures and placeda piece of mesh.They were able to cut to size covering both direct and indirect hernia spaces, sewed into place using an absorbable suture on the top of the mesh and closed the peritoneum over the top suture.The patient committed suicide.

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: UNKNOWN PROGRIP MESH PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8942802
• MDR Text Key: 155929615
• Report Number: 9615742-2019-02907
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PROGRIP MESH PRODUCT
• Device Catalogue Number: UNKNOWN PROGRIP MESH PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR