MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number CL-923

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378)

Event Date 10/27/2023

Event Type  Injury  

Event Description

According to the reporter, postoperatively, a patient was admitted to the hospital in the emergency on (b)(6) 2023, mainly due to "pain in the right lower limb caused by heavy object pressure and limited movement for 4 hours." the diagnosis was "right femoral fracture and right tibial plateau fracture." after completing relevant preoperative examinations, open reduction and internal fixation of right femoral fracture and right tibial plateau fracture were performed on (b)(6) and the reduction was satisfactory.In order to close the incision, the subcutaneous tissue was sutured with 2-0 absorbable sutures, and the operation went smoothly.Seven days after the operation, it was found that the patient's outer right calf wound was red and swollen, showing a suture knot reaction, which led to delayed wound healing.Red light irradiation was given to assist the healing.Ten days after the operation, the wound was obviously red and swollen with yellow-green secretions.Bacterial culture showed methicillin-resistant staphylococcus aureus infection.Vancomycin 500 mg twice a day was immediately administered, combined with levofloxacin 0.5g once a day.After 15+ days of symptomatic anti-infective treatment such as intravenous infusion and enhanced dressing change and drainage, the patient's infection is now better than before and will be discharged after the wound heals.

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: POLYSORB
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• 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: 18375812
• MDR Text Key: 331185006
• Report Number: 1219930-2023-05309
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10884521043404
• UDI-Public: 10884521043404
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K963253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL-923
• Device Catalogue Number: CL-923
• Device Lot Number: A3B0026Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2023
• Date Device Manufactured: 02/01/2023
• 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; Other
• Patient Age: 52 YR
• Patient Sex: Male