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Based on the information provided, it could not be determined that the alleged fungal infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse reported the use of long term antibiotics has predisposed the patient to the development of a yeast infection.The device met specifications before and after patient placement and the manufacturing records for the v.A.C.® dressings met specifications.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 alternative dressing at the direction of the 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.If 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: check the therapy hour meter to ensure that 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.Wound infection: call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever.Your wound is sore, red or swollen.Your skin itches or you have a rash or redness around the wound.The area around the wound feels very warm.You have pus or a bad smell coming from the wound.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.
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On (b)(6) 2021, the following information was reported to kci by the patient: the patient allegedly developed a yeast infection around the wound.The patient has been off of the activ.A.C.¿ ion progress¿ remote therapy monitoring system since (b)(6) 2021 with plans to resume the following week.On (b)(6) 2021, the following information was reported to kci by the wound care nurse: on (b)(6) 2021, v.A.C.® therapy was placed on hold due to a fungal rash to the periwound and an antifungal ointment was prescribed.The patient has had an infection to the wound prior to initiating v.A.C.® therapy and has been on long term antibiotic therapy since (b)(6) 2021.The nurse reported the use of long term antibiotics has predisposed the patient to the development of a yeast infection, and the patient was expected to fully recover.No further information available.Device history record reviews for the v.A.C.® granufoam¿ dressing lot number 8792889v007 and v.A.C.Whitefoam¿ dressing lot number wf20038l1v003 were completed.All end release testing of the products and packaging met specifications.On (b)(6) 2021, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2021, the device was placed with the patient.On (b)(6) 2021, the device was tested per quality control procedure by kci quality engineering and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.
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