V.A.C.® GRANUFOAM¿ Bridge Dressing

Description of Event or Problem

On (b)(6)2026, the following information was provided by the hospital representative: A patient with V.A.C.® GRANUFOAM¿ Bridge Dressing applied to a sacral wound was taken to the operating room with the V.A.C.® Therapy system in place for a procedure on an inguinal wound. An electrosurgical device was used during the procedure. When staff changed the dressing, it was noted that the V.A.C.® Drape was damaged; upon removing the polyurethane foam, it was noted that the base of the wound was completely charred. No additional information available.The V.A.C.® GRANUFOAM¿ Bridge Dressing Lot Number was not provided and was not returned; therefore, a Device Evaluation and a Device History Record review could not be performed.

Additional Manufacturer Narrative

Based on the information provided, it could not be determined that the alleged "charred" base of the wound is related to the V.A.C.® GRANUFOAM¿ Bridge Dressing. The development of dark or black tissue (eschar) is commonly associated with tissue necrosis and is frequently observed in advanced pressure injuries. Multiple unsuccessful attempts were made for additional clinical and device information. A Device Evaluation and a Device History Record review could not be performed. Device labeling, available in print, states:Dressing ChangesWounds 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.Deterioration of the WoundIf 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:-If available on the therapy unit, check the therapy history log to ensure the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day). If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.-Clean wound more thoroughly during dressing changes.-Evaluate for signs and symptoms of infection and, if present, treat accordingly.-Change dressing often, ensuring that it is being changed at least every 48 hours.-Examine the wound and debride as necessary. Debride the wound edges if they 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.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.