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Patient 1
ADDITIONAL DEVICE INFORMATION FOR ACTIV.A.C.? THERAPY UNIT SERIAL NUMBER (B)(4): UNIQUE IDENTIFIER (UDI) (B)(4). DEVICE MANUFACTURE DATE: 25-JAN-2016. OTHER (CODE UNSPECIFIED): V.A.C.? DRAPE IDENTIFIER WAS NOT PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED IRRITATION AND PUS POCKETS ARE RELATED TO THE V.A.C.? DRAPE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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. 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. ACRYLIC ADHESIVE: THE V.A.C.? DRAPE HAS AN ACRYLIC ADHESIVE COATING, WHICH MAY PRESENT A RISK OF AN ADVERSE REACTION IN PATIENTS WHO ARE ALLERGIC OR HYPERSENSITIVE TO ACRYLIC ADHESIVES. IF A PATIENT HAS A KNOWN ALLERGY OR HYPERSENSITIVITY TO SUCH ADHESIVES, DO NOT USE THE V.A.C.? THERAPY SYSTEM. IF ANY SIGNS OF ALLERGIC REACTION OR HYPERSENSITIVITY DEVELOP, SUCH AS REDNESS, SWELLING, RASH, URTICARIA OR SIGNIFICANT SIGNS OF ALLERGIC REACTION APPEAR, SEEK IMMEDIATE MEDICAL ASSISTANCE.