UNIQUE IDENTIFIED (UDI) FOR V.A.C.? GRANUFOAM? DRESSING LOT NUMBER 7062886V009: (B)(4). BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE WOUND EDGES ROLLING INWARDS IS RELATED TO THE ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM. IT IS UNKNOWN IF AND WHAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: DETERIORATION OF THE WOUND IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE / EXPERTISE OF A SPECIALIST: -EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THE APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE. MINIMAL CHANGES IN WOUND SIZE CUT THE FOAM SLIGHTLY SMALLER THAN THE WOUND EDGES FOR WOUNDS WITH LITTLE DEPTH, TO ENHANCE INWARD EPITHELIAL MIGRATION. DO NOT ALLOW THE WOUND EDGES TO ROLL DOWNWARD DURING V.A.C.? THERAPY.
D
Patient 1
ON 27-FEB-2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2020, THE PATIENT WENT ON A V.A.C.? THERAPY BREAK ALLEGEDLY DUE TO THE WOUND BEING SORE. STATED A DIFFERENT NURSE DRESSED THE WOUND AND THINKS THE SORENESS WAS DUE TO THAT. THE PATIENT NO LONGER FEELS SORE SINCE V.A.C.? THERAPY STOPPED. THE NURSE RECOMMENDED TO SEE THE PLASTIC SURGEON ALLEGEDLY DUE TO THE WOUND EDGES ROLLING INWARDS. A DEVICE EVALUATION OF THE ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM IS CURRENTLY PENDING COMPLETION. A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.? GRANUFOAM? DRESSING LOT NUMBER 7062886V009 IS CURRENTLY PENDING COMPLETION.