V.A.C.® GRANUFOAM¿ DRESSING

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, IT COULD NOT BE DETERMINED WHEN THE FOREIGN MATERIAL, ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING, WAS PLACED IN THE WOUND. THE FOREIGN MATERIAL WAS NOT RETURNED FOR IDENTIFICATION; THEREFORE, SOLVENTUM IS UNABLE TO CONFIRM ITS IDENTITY. A DEVICE EVALUATION AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS LEFT IN THE WOUND BEYOND THE MANUFACTURER'S RECOMMENDATIONS; THEREFORE, THIS EVENT IS BEING REPORTED DUE TO POTENTIAL USE ERROR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNING: NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY; OR APPLY AN ALTERNATE DRESSING, SUCH AS A WET TO MOIST GAUZE, AS APPROVED DURING TIMES OF EXTREME NEED, BY TREATING PHYSICIAN. DRESSING CHANGES WOUNDS BEING TREATED WITH THE V.A.C.® THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. FOAM PLACEMENT: ALWAYS USE V.A.C.® DRESSINGS FROM STERILE PACKAGES THAT HAVE NOT BEEN OPENED OR DAMAGED. DO NOT PLACE ANY FOAM DRESSING INTO BLIND / UNEXPLORED TUNNELS. THE V.A.C.® WHITEFOAM¿ DRESSING MAY BE MORE APPROPRIATE FOR USE WITH EXPLORED TUNNELS. DO NOT FORCE FOAM DRESSINGS INTO ANY AREA OF THE WOUND, AS THIS MAY DAMAGE TISSUE, ALTER THE DELIVERY OF NEGATIVE PRESSURE OR HINDER EXUDATE AND FOAM REMOVAL. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM USED IN THE WOUND. DOCUMENT THE FOAM QUANTITY AND DRESSING CHANGE DATE ON THE DRAPE OR FOAM QUANTITY LABEL IF AVAILABLE, AND IN THE PATIENT'S CHART. FOAM REMOVAL: V.A.C.® FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES ARE REMOVED AS WERE PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAN THE RECOMMENDED TIME PERIOD MAY FOSTER INGROWTH OF TISSUE INTO THE FOAM, CREATE DIFFICULTY IN REMOVING THE FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. IF DRESSING ADHERES TO WOUND CONSIDER INTRODUCING STERILE WATER OR NORMAL SALINE INTO THE DRESSING, WAITING 15 - 30 MINUTES, THEN GENTLY REMOVING THE DRESSING FROM THE WOUND. REGARDLESS OF TREATMENT MODALITY, DISRUPTION OF THE NEW GRANULATION TISSUE DURING ANY DRESSING CHANGE MAY RESULT IN BLEEDING AT THE WOUND SITE. MINOR BLEEDING MAY BE OBSERVED AND CONSIDERED EXPECTED. HOWEVER, PATIENTS WITH INCREASED RISK OF BLEEDING, AS DESCRIBED ON PAGE 8, HAVE A POTENTIAL FOR MORE SERIOUS BLEEDING FROM THE WOUND SITE. AS A PRECAUTIONARY STEP, CONSIDER USING V.A.C.® WHITEFOAM¿ DRESSINGS OR NONADHERENT MATERIAL UNDERNEATH THE V.A.C.® GRANUFOAM¿ DRESSINGS TO HELP MINIMIZE THE POTENTIAL FOR BLEEDING AT DRESSING REMOVAL IN THESE PATIENTS. PRECAUTIONS THE V.A.C.® THERAPY SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: ISCHEMIA TO THE INCISION OR INCISION AREA UNTREATED OR INADEQUATELY TREATED INFECTION INADEQUATE HEMOSTASIS OF THE INCISION CELLULITIS OF THE INCISION AREA. INFECTED WOUNDS: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NONINFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS. REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C.® DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS / CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C.® THERAPY SHOULD BE DISCONTINUED. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

ON 29-JUN-2026, THE FOLLOWING INFORMATION WAS OBTAINED VIA CLINICAL DOCUMENTATION REVIEW: PER CLINICAL DOCUMENT, DATED (B)(6) 2026, V.A.C.® THERAPY WAS PLACED ON HOLD DUE TO INCREASED REDNESS AND BLACK SPOTS IN THE WOUND. THE PATIENT STARTED ON AMOXICILLIN, AND THE WOUND WAS DRESSED IN BETADINE. ON (B)(6) 2026, TWO BLACK SPOTS WERE EXCISED AND THE FOREIGN MATERIAL WAS ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING. THE WOUND BASE WAS NOTED TO HAVE HEALTHY GRANULATION TISSUE. ADDITIONALLY, IT WAS RECOMMENDED THAT V.A.C.® THERAPY CONTINUE. ON 30-JUN-2026, THE FOLLOWING INFORMATION RECEIVED VIA FAX FROM THE MEDICAL ASSISTANT WAS REVIEWED: THE MEDICAL ASSISTANT PROVIDED THE CLINICAL NOTE THAT HAD BEEN PREVIOUSLY REVIEWED, DOCUMENTING THAT ON (B)(6) 2026, CURETTAGE WAS PERFORMED AROUND THE ULCER EDGES TO ACHIEVE HEALTHY BLEEDING TISSUE. TWO BLACK SPOTS WERE EXCISED AND IDENTIFIED AS RETAINED V.A.C.® GRANUFOAM¿ DRESSING. THE WOUND BASE EXHIBITED HEALTHY GRANULATION TISSUE, WITH NO PURULENCE OR SIGNS OF ACTIVE INFECTION NOTED. V.A.C.® THERAPY WAS CONTINUED. THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER WAS NOT PROVIDED, AND THE PRODUCT WAS NOT RETURNED; THEREFORE, A DEVICE HISTORY RECORD REVIEW AND DEVICE EVALUATION COULD NOT BE PERFORMED.