MAUDE Adverse Event Report: SURGIPRO; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN SURGIPRO MESH

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Hernia (2240); Distress (2329); Injury (2348); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); No Code Available (3191); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 02/09/2010

Event Type  Injury  

Event Description

According to the reporter: the patient was implanted with one mesh to treat an incisional hernia.Since the initial surgery in 2010, the patient has endured 5 further surgical procedures in an attempt to rectify the debilitating and life threatening complications caused by the hernia mesh.Specifically, the patient has suffered from serious and life threatening complications including, but not limited to, a massive blood clot which was tangled in the mesh, recurrence of the hernia, subsequent loss of tissue around the mesh, infection and surgical attempts to remove the mesh.Since receiving the mesh, the patient has suffered from multiple side effects including but not limited to, chronic and debilitating pain, further surgical care, permanent disfigurement, hernia recurrence, migration of the mesh, bowel obstruction and scar tissue removal.Furthermore, the patient faces future surgical care in an attempt to remove the remaining pieces of the mesh in her abdomen.

Manufacturer Narrative

Additional information: mfg.Site id, a5a, a5b, b2(added life threatening), b5, d8, g3, h6 correction: removed code e2402, updated rational for no return, d2(changed to ftl), d4(model and catalog number), e1(first name, last name, facility name, street 1, city, region, country, postal code and phone number), e3, email of initial reporter, g1(manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email and phone number).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 an incisional hernia.It was reported that after the implant, the patient experienced massive blood clot, recurrence, life threatening complications, subsequent loss of tissue, infection, chronic/debilitating pain, permanent disfigurement, migration of the mesh, bowel obstruction,emotional distress, and scar tissue.Post-operative patient treatment included revision surgeries, scar tissue removal, and surgical attempts to remove the mesh (partial removal of mesh).

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 6944374
• MDR Text Key: 89262583
• Report Number: 9615742-2017-05526
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SURGIPRO MESH
• Device Catalogue Number: UNKNOWN SURGIPRO MESH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• 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): Life Threatening; Other; Required Intervention