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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abscess (1690); Device Embedded In Tissue or Plaque (3165)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

The v.A.C.® 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.It cannot be determined that the alleged abscess is related to v.A.C.® dressing.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.The foreign material was allegedly left in the wound for over the manufacturer's recommendations.This event is being reported due to potential use error.Device labeling, available in print and online, states: transition patients between care settings if the post-acute v.A.C.® therapy unit is not available or discharge, and therapy will be off for more than two hours, remove the v.A.C.® therapy dressings before the patient is discharged.Apply an alternative dressing, such as wet to moist gauze, as approved during times of extreme need, until the new v.A.C.® therapy unit is delivered, and appropriately trained personnel are prepared to provide on-going care of the patient.V.A.C.® therapy should not be discharged with a patient if the clinician has a question about the availability of appropriately trained personnel.V.A.C.® therapy dressings should be removed and an appropriate alternative dressing applied until trained personnel are secured by the healthcare provider and a v.A.C.® therapy unit is delivered.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 20-feb-2022, the following information was reported to kci by the home health agency: the patient moved and has changed home health agencies.The patient was discharged from their agency on (b)(6) 2022 and last wound measurements were taken (b)(6) 2022.On 20-feb-2022, the following information was reported to kci by the patient's family member: due to the patient relocating, there was a delay in the patient's care when changing home health agencies.On (b)(6) 2022, the home health nurse noted a foreign material alleged to be v.A.C.® dressing was adhered to the patient's wound, and the patient presented to the hospital.The foreign material was surgically removed, and the family member noted the wound to be healing very well.No additional information was provided.On 09-mar-2022, the following information was reported to kci by the nurse case manager: on (b)(6) 2022, the nurse was unable to remove the v.A.C.® dressing and sent patient to the emergency room.The patient was admitted to the hospital on (b)(6)2022 and no notation of surgical removal.On 10-mar-2022, the following information was reported to kci by the registered nurse case manager: the patient was seen on (b)(6) 2022 and sent to the emergency room due to adhered v.A.C.® dressing.Per the patient's granddaughter, the v.A.C.® dressing had not been changed in one week.Hospital records note, on (b)(6) 2022, the patient developed an abscess and incision and drainage, in operating room, was scheduled for following day.Patient was treated with intravenous antibiotics.No lot number provided.The v.A.C.® dressing lot number was not provided and the product was not returned; therefore, a device history record review and device evaluation could not be performed.

• Brand Name: V.A.C.® 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: 13736151
• MDR Text Key: 287029254
• Report Number: 3009897021-2022-00052
• 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: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2022

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
• Initial Date Manufacturer Received: 02/20/2022
• Initial Date FDA Received: 03/11/2022
• 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: 62 YR
• Patient Sex: Female