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The device identifier was not provided and the product was not returned for evaluation; therefore, a device evaluation could not be performed.Based on information provided, it cannot be determined that the alleged hospitalization and purulent drainage requiring antibiotic therapy are related to the v.A.C.Whitefoam¿ dressing.The patient has a history of infection prior to initiating v.A.C.® therapy.Additionally, kci cannot determine when the foreign body alleged to be v.A.C.Whitefoam¿ dressing was placed in the wound.The foreign material was discarded and was not returned to kci for identification; therefore, kci is unable to confirm its identity.This event is being reported as a potential use error.The date of the event is (b)(6) 2019.Kci was made aware of the event on 11-nov-2019 via medwatch form mw5090675.Upon review, it was discovered that this mdr was inadvertently not filed.Therefore, this is a late submission.Device labeling, available in print and online, states: warning: 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.Foam placement: always use v.A.C.® dressings from sterile packages that have not been opened or damaged.Do not place any foam dressing into blind / unexplored tunnels.The v.A.C.® whitefoam¿ dressing may be more appropriate for use with explored tunnels.Do not force foam dressings into any area of the wound, as this may damage tissue, alter the delivery of negative pressure or hinder exudate and foam removal.Always count the total number of pieces of foam used in the wound.Document the foam quantity and dressing change date on the drape or foam quantity label if available, and in the patient's chart.Foam removal: v.A.C.® foam dressings are not bioabsorbable.Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces are removed as were placed.Foam left in the wound for greater that the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing the foam from the wound or lead to infection or other adverse events.If dressing adheres to wound consider introducing sterile water or normal saline into the dressing, waiting 15 - 30 minutes, then gently removing the dressing from the wound.Regardless of treatment modality, disruption of the new granulation tissue during any dressing change may result in bleeding at the wound site.Minor bleeding may be observed and considered expected.However, patients with increased risk of bleeding, as described on page 8, have a potential for more serious bleeding from the wound site.As a precautionary step, consider using v.A.C.® whitefoam¿ dressings or nonadherent material underneath the v.A.C.® granufoam¿ dressings to help minimize the potential for bleeding at dressing removal in these patients.
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On (b)(6) 2019, the following information was reported to kci via medwatch report mw5090675: the patient had surgery to "repair a leak from a prior abdominal aortic aneurysm repair in (b)(6) 2019 and an incision and drainage was performed on the left groin incision for evidence of infection and wound breakdown." v.A.C.® therapy was placed with one v.A.C.Whitefoam¿ piece and three v.A.C.® granufoam¿ pieces.The following day, the patient was placed on a wet to dry dressing for transition to home health and v.A.C.® therapy with black granufoam¿ per provider's orders."the wound initially appeared to be healing; however, in early (b)(6), evidence of purulent drainage was discovered.V.A.C.® therapy was removed and the patient was admitted for imaging and placed on antibiotics.Imaging showed evidence of fluid collection.The patient was taken for exploratory surgery on (b)(6)" in which a piece of foreign material alleged to be v.A.C.Whitefoam¿ dressing was discovered and removed.The patient was discharged on "(b)(6) 2019." it was indicated that the retained material was not radiopaque and the white color blended in with the tissue making it difficult to see, therefore, not identified upon patient's return.The v.A.C.Whitefoam¿ dressing identifier was not available and the product was not returned; therefore, a device history record review and a device evaluation could not be performed.
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