inforMED
InjuryLMF

SURGIFLO¿ HAEMOSTATIC MATRIX

Received May 21, 2026 · Event occurred Apr 3, 2026

Report 3008478369-2026-00014 · MDR key 25238424

Device

Generic name

Agent, Absorbable Hemostatic, Collagen Based

Model number

MS0010

Lot number

280086

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Fever
  • Rash
  • Impaired Healing
  • Post Operative Wound Infection

Narrative

Description of Event or Problem

POST-OP INFLAMMATION & POOR WOUND HEALING & POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. AFTER ADMISSION, THE PATIENT COMPLETED RELEVANT EXAMINATIONS AND TESTS, INDICATING HIGH INFECTION INDICATORS. AFTER CONSULTATION WITH A SPECIALIST, ACTIVE ANTI INFECTION TREATMENT WAS CARRIED OUT. AFTER SIGNIFICANT IMPROVEMENT IN THE RELEVANT INFECTION INDICATORS, SURGERY WAS SCHEDULED. FLUID GELATIN AND HEMOSTATIC GAUZE WERE USED DURING THE OPERATION, AND THE SURGERY WENT SMOOTHLY. THE POSTOPERATIVE RECOVERY WAS GOOD, THE WOUND HEALING WAS GOOD, AND THE REPORTED SYMPTOMS IMPROVED COMPARED TO BEFORE SURGERY. THE PATIENT HAD AND GRADUALLY PERFORMED FUNCTIONAL EXERCISE UNDER THE PROTECTION OF SUPPORT. POSTOPERATIVE IMAGING EXAMINATION SHOWED GOOD INTERNAL FIXATION IN PLACE. 5 DAYS AFTER SURGERY, THE PATIENT EXPERIENCED INTERMITTENT FEVER WITHOUT OBVIOUS CAUSE, WITH A BODY TEMPERATURE OF 39.9 ?. SYMPTOMATIC TREATMENT WAS GIVEN FOR FEVER REDUCTION, ANTI-INFLAMMATORY, FLUID REPLACEMENT, AND LIVER PROTECTION, AND RELEVANT EXAMINATIONS AND TESTS WERE ACTIVELY IMPROVED TO CLARIFY THE CAUSE OF THE FEVER. ON THE NINTH DAY AFTER SURGERY, THE PATIENT DEVELOPED HIGH FEVER AND A LARGE RASH ALL OVER THE BODY. RELEVANT DEPARTMENTS WERE URGENTLY CONSULTED AND TREATMENT WAS GIVEN AS INSTRUCTED. THE SYMPTOMS CONTINUED TO PERSIST AND THE PATIENT AND THEIR FAMILY WERE FULLY INFORMED OF THE CONDITION. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER TREATMENT. ON THE 10TH DAY AFTER SURGERY, THE BACTERIAL CULTURE SHOWED STAPHYLOCOCCUS EPIDERMIDIS. ON THE 11TH DAY AFTER SURGERY, POOR WOUND HEALING WAS OBSERVED DURING DRESSING CHANGE, INDICATING WOUND INFECTION. SURGERY WAS PERFORMED AGAIN, AND CONTINUED WITH ANTI INFECTION, LIVER PROTECTION, FLUID REPLACEMENT, AND OTHER TREATMENTS TO ALLEVIATE SYMPTOMS. REGULAR DRESSING CHANGES WERE CONTINUED, AND BACTERIAL CULTURE AND INFLAMMATORY INDEX TESTING WERE PERFORMED. BASED ON THE CORRESPONDING RESULTS, CLINICAL PHARMACY CONSULTATION WAS SOUGHT TO GUIDE ANTI INFECTION TREATMENT. INTRAOPERATIVE AND POSTOPERATIVE USE OF PIPERACILLIN TAZOBACTAM FOR ANTI INFECTIVE TREATMENT. NO DEVICE IS AVAILABLE FOR EVALUATION. EVENT DATE: 04/03/2026 PROCEDURE DATE: (B)(6) 2026. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED STATING: RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN.