V.A.C.® DRAPE

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FUNGAL INFECTION REQUIRING MEDICATION IS RELATED TO THE V.A.C.® DRAPE. A DEVICE EVALUATION AND A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS KEEP V.A.C.® THERAPY ON: 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. 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 (B)(6) 2026, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: V.A.C.® THERAPY WAS DISCONTINUED ON (B)(6) 2026 DUE TO THE PATIENT EXPERIENCING A REACTION TO THE V.A.C.® DRESSING. A YEAST INFECTION DEVELOPED AROUND THE ENTIRE WOUND AREA. ON (B)(6) 2026, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: V.A.C.® THERAPY WAS DISCONTINUED DURING A PHYSICIAN APPOINTMENT ON (B)(6) 2026 DUE TO A REACTION FROM THE V.A.C.® DRAPE RESULTING IN A FUNGAL INFECTION TO THE PATIENT¿S SURROUNDING SKIN. THE PATIENT WAS PRESCRIBED NYSTATIN POWDER FOR TREATMENT, AND THE WOUND HAS SINCE IMPROVED. THE V.A.C.® DRESSING LOT NUMBER WAS NOT PROVIDED, AND THE DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE HISTORY RECORD REVIEW AND A DEVICE EVALUATION COULD NOT BE PERFORMED.