LIQUIBANDFIX8® OPEN HERNIA MESH FIXATION DEVICE

Additional Manufacturer Narrative

ADVERSE EVENT WAS RECEIVED AS PART OF A CLINICAL STUDY. (B)(6) OCCURRED ON (B)(6) 2024, BUT WAS NOT REPORTED TO THE SITE UNTIL THE 06TH JUNE 2025. STUDY: (B)(6). SITE: 005 --- (B)(6) HOSPITAL. SUBJECT: (B)(6). ADVERSE EVENT SEQUENCE : AE-001. ADVERSE EVENT TYPE : INFECTION. ADVERSE EVENT TERM (USE MEDICAL DIAGNOSIS FOR EVENT TERM IF AVAILABLE): : INFECTION. EVENT DESCRIPTION : NON-HEALING INCISIONAL WOUND ADJACENT TO THE RIGHT GROIN. THE MIDDLE TO OPPOSITE DISTAL PART OF THE WOUND. HEALED AS PER PATIENT. EVENT ONSET DATE : 12-JUN-2024. DATE SITE LEARNED OF EVENT : 06-JUN-2025. SEVERITY : MILD. EVENT RELATED TO STUDY DEVICE? : POSSIBLY RELATED. EVENT RELATED TO STUDY PROCEDURE? : POSSIBLY RELATED. WAS THIS EVENT RELATED TO A DEVICE DEFICIENCY/DEVICE MALFUNCTION/DEVICE MISUSE/USER ERROR? : NO. SERIOUS ADVERSE EVENT? : NO. DATE SPONSOR WAS NOTIFIED: : 06-JUN-2025. DOES EVENT REQUIRE REPORTING TO EC? : NO. MEDICATION : YES. IF YES, PLEASE SPECIFY MEDICATION/S PROVIDED: : ANTIBIOTICS (UNABLE TO RECALL EXACT DRUG NAME). SURGERY/PROCEDURE: : NO. OTHER TREATMENT : YES. PLEASE SPECIFY OTHER TREATMENT PROVIDED: : GP VISIT FOR WOUND CLEANING AND DRESSING CHANGES. EVENT OUTCOME: : RECOVERED. IF RECOVERED, OR FATAL, DATE OF RESOLUTION: : 18-JUL-2024. AS PER FDA 21 CFR 803.3, A 'SERIOUS INJURY' IS DEFINED AS: 'AN INJURY OR ILLNESS THAT: · IS LIFE THREATENING; · RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR · NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.' AMS CANNOT CONCLUDE THAT THIS ADVERSE EVENT WAS DEVICE-RELATED. HOWEVER, AS THIS EVENT REQUIRED MEDICAL INTERVENTION, IN THE FORM OF ANTIBIOTICS, TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY AND IS BEING REPORTED IN THE USA.

Description of Event or Problem

MFR REPORT #: 9617175-2025-00013 STUDY: (B)(4). SITE: 005 --- (B)(6) HOSPITAL. SUBJECT: (B)(6). ADVERSE EVENT SEQUENCE : AE-001. ADVERSE EVENT TYPE : INFECTION. ADVERSE EVENT TERM (USE MEDICAL DIAGNOSIS FOR EVENT TERM IF AVAILABLE): : INFECTION. EVENT DESCRIPTION : NON-HEALING INCISIONAL WOUND ADJACENT TO THE RIGHT GROIN. THE MIDDLE TO OPPOSITE DISTAL PART OF THE WOUND. HEALED AS PER PATIENT. EVENT ONSET DATE : 12-JUN-2024. DATE SITE LEARNED OF EVENT : 06-JUN-2025. SEVERITY : MILD. EVENT RELATED TO STUDY DEVICE? : POSSIBLY RELATED. EVENT RELATED TO STUDY PROCEDURE? : POSSIBLY RELATED. WAS THIS EVENT RELATED TO A DEVICE DEFICIENCY/DEVICE MALFUNCTION/DEVICE MISUSE/USER. ERROR? : NO. SERIOUS ADVERSE EVENT? : NO. DATE SPONSOR WAS NOTIFIED: : 06-JUN-2025. DOES EVENT REQUIRE REPORTING TO EC? : NO. MEDICATION : YES. IF YES, PLEASE SPECIFY MEDICATION/S PROVIDED: : ANTIBIOTICS (UNABLE TO RECALL EXACT DRUG NAME). SURGERY/PROCEDURE: : NO. OTHER TREATMENT : YES. PLEASE SPECIFY OTHER TREATMENT PROVIDED: : GP VISIT FOR WOUND CLEANING AND DRESSING CHANGES. EVENT OUTCOME: : RECOVERED. IF RECOVERED, OR FATAL, DATE OF RESOLUTION: : 18-JUL-2024.