MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. WHITEFOAM DRESSING; OMP

Model Number	VACDSP
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the v.A.C.Whitefoam¿ dressing was not returned; therefore, a device evaluation could not be performed.Based on information provided, kci could not determine what issues the patient experienced with the wound or when the foreign material alleged to be v.A.C.Whitefoam¿ dressing was placed in the wound.The family member stated the nurse reportedly left v.A.C.Whitefoam¿ dressing in the patient's wound; however, it fell out upon admission to the hospital.The patient continued v.A.C.® therapy at the hospital and a foreign material was debrided from the wound bed.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.Kci has made multiple unsuccessful attempts to obtain additional clinical information.This event is being reported as a potential use error.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.
Event or Problem Description
On 23-apr-2021, the following information was provided to kci by the patient's family member: on (b)(6) 2021, the patient was admitted to the hospital.On 23-apr-2021, the following information was provided to kci by the patient's family member: the patient was admitted to the hospital on (b)(6) 2021, allegedly due to an issue with the wound.The nurse reportedly could not locate a piece of v.A.C.Whitefoam¿ dressing in the wound.When the patient arrived at the hospital, the v.A.C.® dressing was removed and a foreign material alleged to be v.A.C.Whitefoam¿ dressing fell out of the wound cavity.The patient is in the hospital for observation.On 27-apr-2021, the following information was provided to kci by the nurse: the patient allegedly underwent a bedside surgical debridement of "versa foam".No additional information available.On (b)(6) 2021, a device history record review for the v.A.C.Whitefoam¿ dressing was completed.All end release testing of the product and packaging met specifications.

• Brand Name: V.A.C. WHITEFOAM DRESSING
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 11868517
• Report Number: 3009897021-2021-00084
• Device Sequence Number: 19063319
• Product Code: OMP
• UDI-Device Identifier: 00849554003286
• UDI-Public: 01008495540032861722092510WF20032L1V003
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K133276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: VACDSP
• Device Catalogue Number: M6275033
• Device Lot Number: WF20032L1V003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 79