SURGIFLO¿ HAEMOSTATIC MATRIX
Received Apr 23, 2025 · Event occurred Mar 4, 2025
Report 3008478369-2025-00011 · MDR key 21888475
Device
Generic name
Agent, Absorbable Hemostatic, Collagen Based
Manufacturer
Ferrosan Medical Devices A/sModel number
MS0010Lot number
275647
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR · Male
- Impaired Healing
- Impaired Healing
Narrative
Description of Event or Problem
WOUND SECRETION AND POOR WOUND HEALING. THE PATIENT WAS HOSPITALIZED DUE TO LUMBAR SPINAL STENOSIS AND UNDERWENT SURGERY 3 DAYS LATER. HEMOSTATIC FLUID GELATIN WAS USED DURING THE SURGERY. THE SURGERY WAS SMOOTH AND THE PATIENT RECOVERED WELL AFTER THE SURGERY. THE PATIENT WAS DISCHARGED FOR REHABILITATION EXERCISE TREATMENT. AFTER THE PATIENT WAS DISCHARGED, THE WOUND WAS REGULARLY CHANGED IN DRESSING. DURING THE DRESSING CHANGE, A SMALL AMOUNT OF EXUDATE WAS FOUND IN THE LOWER PART OF THE WOUND AND CONTINUED TO INSIST ON CLEANING AND CHANGING THE DRESSING, BUT THE WOUND STILL HEALED POORLY. THE PATIENT CONTACTED OUR HOSPITAL AND WAS ADMITTED AGAIN FOR FURTHER TREATMENT. AFTER COMPLETING RELEVANT EXAMINATIONS, SURGICAL CONTRAINDICATIONS WERE EXCLUDED AND SURGICAL TREATMENT WAS PERFORMED. AFTER THIS SURGERY, THE PATIENT'S WOUND HEALED WELL. PATIENT: 52-YEAR-OLD MALE. EVENT DATE: 03/04/2025. PROCEDURE DATE: UNK.