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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body Reaction (1868); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the first date of onset is unknown.It was reported the patient was admitted to hospital on (b)(6) 2021 and had stated to notice an increase in swelling, redness and drainage over the past few days.Thus, (b)(6) 2021 was utilized.V.A.C.Whitefoam¿ dressing lot number was not available and the dressing was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on information provided, kci cannot determine when the foreign material alleged to be v.A.C.® dressing was placed in the wound.The patient was utilizing both v.A.C.Whitefoam¿ dressing and v.A.C.® granufoam¿ dressing.Additionally, kci is unable to determine if the alleged increase in swelling, redness and drainage are related to the v.A.C.Whitefoam¿ dressing.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.The patient discontinued v.A.C.® therapy on (b)(6) 2021.The foreign material was allegedly left in the wound for over the manufacturer's recommendations.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.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 Description

On 07-apr-2021, the following clinical records from the hospital were reviewed by kci: on (b)(6) 2021, the patient was admitted to the hospital for abdominal wall drainage and pain.It was noted that v.A.C.® therapy was recently discontinued but the wound had not completely closed and was still draining.Over the past few days, the patient started noticing increased swelling, redness, and drainage from her abdominal wound in the periumbilical area.The patient was admitted for an excisional debridement.On (b)(6) 2021, the patient underwent an excisional debridement of a chronic non-healing abdominal wound and three pieces of foreign material alleged to be v.A.C.® dressing were identified and surgically excised.Per kci records the patient was discontinued from v.A.C.® therapy on (b)(6) 2021 and the patient was utilizing both v.A.C.Whitefoam¿ dressing and v.A.C.® granufoam¿ dressing.No additional information available.The v.A.C.Whitefoam¿ dressing and v.A.C.® granufoam¿ dressing lot numbers were not available, and the products were not returned; therefore, device history reviews and device evaluations could not be performed.Refer to mdr 3009897021-2021-00106 for the v.A.C.® granufoam¿ dressing.Refer to mdr for the v.A.C.Whitefoam¿ dressing.

• Brand Name: V.A.C. WHITEFOAM DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 11777673
• MDR Text Key: 264521733
• Report Number: 3009897021-2021-00100
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 05/05/2021

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
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80