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 Problem Fungal Infection (2419)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

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.Based on the information provided, it cannot be determined that the alleged fungal infection requiring medication is related to the v.A.C.® drape.The patient has a reported history of perspiring which has increased due to the temperature outside.The wound is located in the lower back where a pilonidal cystectomy was performed.Device labeling, available in print and online, states: warnings: 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.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.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.

Event Description

On 16-may-2022, the following information was provided to kci by the patient's family member: the patient broke out on (b)(6) 2022 due to sweat so the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed and placed back on today.The patient has a yeast infection where the v.A.C.® drape is placed and has a rash underneath the v.A.C.® drape due to the temperature outside.The physician ordered antifungal medication and for the area to air dry.On 26-may-2022, the following information was provided to kci by the wound care nurse: on (b)(6) 2022, the patient experienced redness to the periwound and per the spouse, there were blisters present, although none were observed at the wound care center.There was no fungal odor noted, however, the patient has been on v.A.C.® therapy since december and has never experienced skin irritation so the redness was attributed to a fungal infection.Diflucan oral tablet was ordered.On (b)(6) 2022, a second dose of diflucan was ordered as well as lotrisone cream, and the activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold.The fungal infection cleared up and v.A.C.® therapy has resumed.The v.A.C.® dressing lot number was not provided and the product was not returned; therefore, a device evaluation and a device history record review could not be performed.

• Brand Name: V.A.C.® DRAPE
• 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: 14685946
• MDR Text Key: 294883262
• Report Number: 3009897021-2022-00114
• 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: 06/14/2022

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: 05/16/2022
• Initial Date FDA Received: 06/14/2022
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Transgender