MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 2-0 UNI MONODERM 20CM

Model Number VLM-1006

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/08/2021

Event Type  Injury  

Event Description

Wound healing difficulty, no details were initially received adrs# report code (b)(4) updated 10/14 the patient underwent surgery for appendicitis on (b)(6) 2021.The appendix was removed, and the incision was sutured.But the wound did not recover, and infection was seen during the hot weather.He came to the hospital for a review on (b)(6) 2021.

Manufacturer Narrative

A batch review of the finished good lot, sterility records and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.No samples or photos were available for review.If samples, photos, or additional information becomes available at a later date, the samples, photos or information will be reviewed and added to the file.A follow-up report will be submitted at that time.The precautions section of the ifu states, ¿infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with the barbed suture device comprised of pga/pcl material.¿ the adverse reaction section of the ifu for the device states, ¿adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply.¿ without receiving photos of the surgical site/reaction or receiving detailed information regarding the procedure performed, placement of the suture in the tissue, surgeon¿s technique, patient¿s health history including past reactions to suture material, quality of the surrounding tissue, post-op instructions and/or events that may have occurred; contributed to the event, results of the culture / tests, a definitive root cause for the reported event cannot be confirmed with certainty.

• Brand Name: QUILL
• Type of Device: 2-0 UNI MONODERM 20CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 15663811
• MDR Text Key: 302337228
• Report Number: 3010692967-2022-00049
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10848782020116
• UDI-Public: (01)10848782020116(17)240731(10)AAEQ338
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072028
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2022,10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: VLM-1006
• Device Lot Number: AAEQ338
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 10/14/2022
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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
• Patient Sex: Male