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

Model Number VACDSP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fungal Infection (2419); Skin Inflammation/ Irritation (4545)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged fungal infection and skin irritation requiring medication are related to the v.A.C.® drape.Multiple unsuccessful attempts were made to obtain additional clinical information.A device history record review of the v.A.C.® granufoam¿ dressing and associated v.A.C.® drape met specifications.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.Precautions.The v.A.C.® therapy system will not be effective in addressing complications associated with the following: -ischemia to the incision or incision area; -untreated or inadequately treated infection; -inadequate hemostasis of the incision; -cellulitis of the incision area.Protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile / friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.-multiple layers of v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration.-if any signs of irritation or sensitivity to the drape, foam, or tubing assembly appear, discontinue use and consult a physician.-to avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing during drape application.-extra caution should be used for patients with neuropathic etiologies or circulatory compromise.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

Event Description

On (b)(6) 2023, the following information was provided to kci by the patient: on (b)(6) 2023, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold due to an alleged fungal infection and skin irritation to peri-wound, possibly from the v.A.C.® drape.Nystatin cream is being used and an alternative wet to dry dressing is in place.The wound is to be reassessed at her follow up appointment with the provider to determine if v.A.C.® therapy will be resumed.No additional information was provided.On (b)(6) 2023, a device history record review for the v.A.C.® granufoam¿ dressing lot number a11028v009 and associated v.A.C.® drape was completed.All end release testing of product and packaging met specifications.The v.A.C.® granufoam¿ dressing was not returned; therefore, a device evaluation could not be performed.

• Brand Name: V.A.C.® DRAPE
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 16761084
• MDR Text Key: 313500325
• Report Number: 3009897021-2023-00035
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 01008495540020981725103110A11028V009
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: A11028V009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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
• Treatment: AMLODIPINE 5MG PO DAILY.; LEVOTHYROXINE 200 MCG PO DAILY.; LOSARTAN 50MG PO DAILY.; MELOXICAM 7.5MG.; PRAVASTATIN 20MG PO DAILY.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female