MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V STRATAFIX; SH 2-0 MONODERM 20CM

Model Number	SXMD1B405
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.The actual sample was not returned for review.If samples or photos become available at a later time, they will be review/tested and the results will be included as part of the investigation file.A follow-up report will be submitted at that time.Adverse events including wound dehiscence and reactions/rashes are common risks/complications of any surgical procedure.There are many causes that can result in the wound opening, sutures failing or reaction, infection, abscess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition.Past reactions to suture material or medications.The placement of the suture, over-tightening of the material without receiving information regarding the incisions/post-operative conditions, results of cultures or tests to identify infection or receiving pertinent details regarding the procedures performed, placement of the suture material, condition of the tissue where the suture was placed, patient's health status, post-operative event(s) that may have contributed to the reported conditions, number of days post-operative when the rashes presented or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
On 31-oct-2024, it was reported that a patient's surgical site exhibited redness and suppuration.The patient was admitted to a higher-level hospital for infection control, where the suture was removed and re-sutured.
Additional Manufacturer Narrative
It was reported by our distributor, the event date is unknown.The patient's wound healing was improved after symptomatic treatment, and no subsequent adverse event report was received.

• Brand Name: STRATAFIX
• Common Device Name: SH 2-0 MONODERM 20CM
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE R.L. DE C.V; corredor tijuana rosarito 2000; #24702 b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20845769
• Report Number: 3010692967-2024-00111
• Device Sequence Number: 12787258
• Product Code: GAM
• UDI-Device Identifier: 10705031228061
• UDI-Public: 10705031228061
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: SXMD1B405
• Device Lot Number: E221QVF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female