MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGIPRO; MESH, SURGICAL, POLYMERIC

Model Number SPM-66-W

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Impaired Healing (2378); Fluid Discharge (2686); Fibrosis (3167); Pyogenic Infection (4554); 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 incisional hernia.It was reported that after the implant, the patient experienced mesh failure, pain, abdominal pain, gastrointestinal malfunction, grotesque swelling, scarring, disfigurement, loss of enjoyment of life, permanent physical disability, loss of physical, mental & emotional health, defective device, scar tissue, hernia recurrence, inflamed granulation tissue, abdominal wound, staphylococcus aureus; coryneform bacteria , abnormal erythrocyte sedimentation rate, fibroadipose tissue, fibrosis, foreign body reaction, chronic inflammation, wound dehiscence, abscess, wound drainage, red open wound, draining pus and serosanguinous fluid, pyrogenic granuloma of abdominal wall, infection, purulent drainage, dehiscence, erythema, non-healing wound, wound tract, & sinus tract.Post-operative patient treatment included revision surgery, removal of mesh, antibiotics, abscess incision and drainage, removal of infected suture, partial removal of mesh, wound vac, multiple mesh debridement's, & incision and drainage of left sinus tract.

Manufacturer Narrative

Adverse event problem: ime e2402: abnormal erythrocyte sedimentation rate, fibroadipose tissue, sinus tract.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: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16383252
• MDR Text Key: 309642825
• Report Number: 1219930-2023-00575
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101388
• UDI-Public: 10884521101388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• 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
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: SPM-66-W
• Device Catalogue Number: SPM-66-W
• Device Lot Number: A4E1378X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2023
• Date Device Manufactured: 05/23/2014
• 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
• Treatment: UNKNOWN PROLENE MESH.
• Patient Outcome(s): Required Intervention; Disability