V.A.C. SIMPLICITY¿ THERAPY UNIT

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED BLEEDING EVENT IS RELATED TO THE V.A.C. SIMPLICITY¿ THERAPY UNIT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL CLINICAL INFORMATION. THE DEVICE PASSED QUALITY CONTROL CHECKS BEFORE PATIENT PLACEMENT, AND A DEVICE EVALUATION AFTER PLACEMENT COULD NOT BE PERFORMED. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: CONTRAINDICATIONS DO NOT PLACE FOAM DRESSINGS OF THE 3M¿ V.A.C.® THERAPY SYSTEM DIRECTLY IN CONTACT WITH EXPOSED BLOOD VESSELS, ANASTOMOTIC SITES, ORGANS, OR NERVES. NOTE: REFER TO WARNINGS SECTION FOR ADDITIONAL INFORMATION CONCERNING BLEEDING. 3M¿ V.A.C.® THERAPY IS CONTRAINDICATED FOR PATIENTS WITH: MALIGNANCY IN THE WOUND , UNTREATED OSTEOMYELITIS . NOTE: REFER TO WARNINGS SECTION FOR OSTEOMYELITIS INFORMATION. NON-ENTERIC AND UNEXPLORED FISTULAS NECROTIC TISSUE WITH ESCHAR PRESENT NOTE: AFTER DEBRIDEMENT OF NECROTIC TISSUE AND COMPLETE REMOVAL OF ESCHAR, 3M¿ V.A.C.® THERAPY MAY BE USED. SENSITIVITY TO SILVER (3M¿ V.A.C.® GRANUFOAM SILVER¿ DRESSING ONLY) WARNINGS BLEEDING: WITH OR WITHOUT USING 3M¿ V.A.C.® THERAPY, CERTAIN PATIENTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PATIENTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. PATIENTS WHO HAVE WEAKENED OR FRIABLE BLOOD VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTAMOSIS OR GRAFTS)/ORGAN, INFECTION , TRAUMA , RADIATION , PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS , PATIENTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS, PATIENTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES . IF 3M¿ V.A.C.® THERAPY IS PRESCRIBED FOR PATIENTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING 3M¿ V.A.C.® THERAPY, OR IF FRANK (BRIGHT RED) BLOOD IS SEEN IN THE TUBING OR IN THE CANISTER, IMMEDIATELY STOP 3M¿ V.A.C.® THERAPY, LEAVE DRESSING IN PLACE, TAKE MEASURES TO STOP THE BLEEDING, AND SEEK IMMEDIATE MEDICAL ASSISTANCE. THE 3M¿ ACTIV.A.C.¿ THERAPY UNIT AND 3M¿ V.A.C.® DRESSINGS SHOULD NOT BE USED TO PREVENT, MINIMIZE OR STOP VASCULAR BLEEDING. PROTECT VESSELS AND ORGANS: ALL EXPOSED OR SUPERFICIAL VESSELS AND ORGANS IN OR AROUND THE WOUND MUST BE COMPLETELY COVERED AND PROTECTED PRIOR TO THE ADMINISTRATION OF 3M¿ V.A.C.® THERAPY. ALWAYS ENSURE THAT THE 3M¿ V.A.C.® DRESSING FOAM DOES NOT COME IN DIRECT CONTACT WITH VESSELS OR ORGANS. USE OF A THICK LAYER OF NATURAL TISSUE SHOULD PROVIDE THE MOST EFFECTIVE PROTECTION. IF A THICK LAYER OF NATURAL TISSUE IS NOT AVAILABLE OR IS NOT SURGICALLY POSSIBLE, MULTIPLE LAYERS OF MESHED, NON-ADHERENT MATERIAL, OR BIO-ENGINEERED TISSUE MAY BE CONSIDERED AS AN ALTERNATIVE, IF DEEMED BY THE TREATING PHYSICIAN TO PROVIDE A COMPLETE PROTECTIVE BARRIER. IF USING NON-ADHERENT MATERIALS, ENSURE THAT THEY ARE SECURED IN A MANNER THAT WILL MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY. CONSIDERATION SHOULD ALSO BE GIVEN TO THE NEGATIVE PRESSURE SETTING AND THERAPY MODE USED WHEN INITIATING THERAPY. CAUTION SHOULD BE TAKEN WHEN TREATING LARGE WOUNDS THAT MAY CONTAIN HIDDEN VESSELS, WHICH MAY NOT BE READILY APPARENT. THE PATIENT SHOULD BE CLOSELY MONITORED FOR BLEEDING IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN. INFECTED BLOOD VESSELS: INFECTION MAY ERODE BLOOD VESSELS AND WEAKEN THE VASCULAR WALL WHICH MAY INCREASE SUSCEPTIBILITY TO VESSEL DAMAGE THROUGH ABRASION OR MANIPULATION. INFECTED BLOOD VESSELS ARE AT RISK OF COMPLICATIONS, INCLUDING BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL. EXTREME CAUTION SHOULD BE USED WHEN 3M¿ V.A.C.® THERAPY IS APPLIED IN CLOSE PROXIMITY TO INFECTED OR POTENTIALLY INFECTED BLOOD VESSELS (REFER TO PROTECT VESSELS AND ORGANS SECTION.). 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'S FAMILY MEMBER: THE PATIENT EXPERIENCED AN ADVERSE BLEEDING EVENT DUE TO AN ALLEGED TECHNICAL ISSUE WHEN PLACED ON THE V.A.C. SIMPLICITY¿ THERAPY SYSTEM. THE PATIENT WAS READMITTED TO THE HOSPITAL AND REMAINS UNDER TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 30-OCT-2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE UNIT PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.