SURGIFLO¿ HAEMOSTATIC MATRIX
Received Aug 19, 2025 · Event occurred Jun 25, 2025
Report 3008478369-2025-00037 · MDR key 22837102
Device
Generic name
Agent, Absorbable Hemostatic, Collagen Based
Manufacturer
Ferrosan Medical Devices A/sModel number
MS0010Lot number
277297
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Impaired Healing
- Post Operative Wound Infection
- Impaired Healing
- Post Operative Wound Infection
Narrative
Description of Event or Problem
POOR WOUND HEALING. SUTURE WAS USED DURING THE SURGERY, ABSORBABLE HEMOSTATIC GAUZE WAS USED FOR LOCAL HEMOSTASIS, AND FLUID GELATIN WAS USED FOR LOCAL HEMOSTASIS. DURING THE OUTPATIENT FOLLOW-UP ONE MONTH AFTER SURGERY, THE SUPERVISING DOCTOR FOUND THAT THE WOUND ON THE PATIENT'S WAIST AND BACK HAD NOT HEALED PROPERLY. UPON FURTHER INVESTIGATION OF THE PATIENT'S MEDICAL HISTORY, IT WAS FOUND THAT THE PATIENT HAD UNDERGONE WOUND DRESSING CHANGES AT HOME AFTER DISCHARGE, WHICH MAY HAVE BEEN DUE TO IMPROPER PROCEDURES. ADDITIONALLY, THE PATIENT HAS A CONSTITUTION THAT IS PRONE TO REJECTION REACTIONS, AND THE WOUND CONDITION CANNOT RULE OUT THE POSSIBILITY OF ABSORBABLE HEMOSTATIC GAUZE, FLUID GELATIN REJECTION REACTION, AND INFECTION. IT IS RECOMMENDED THAT THE PATIENT BE HOSPITALIZED FOR TREATMENT. THE PATIENT WAS READMITTED ON THE 36TH DAY AFTER SURGERY. ON THE 39TH DAY AFTER SURGERY, THE PATIENT UNDERWENT LUMBAR SPINE WOUND DEBRIDEMENT, PERFUSION IRRIGATION AND DRAINAGE SURGERY. VISIBLE CHANGES IN THE WOUND SURFACE SHOW A LINEAR REACTION, WITH SOME TISSUES APPEARING GRAYISH YELLOW. THE DOCTOR COMPLETELY REMOVED THE ORIGINAL INCISION SUTURE. THE WOUND IS NOW HEALED AND DISCHARGED FROM THE HOSPITAL. NO PRODUCT IS AVAILABLE FOR EVALUATION. EVENT DATE: 06/25/2025. PROCEDURE DATE: (B)(6) 2025.