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 03/01/2024

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged fungal infection requiring medication is related to the v.A.C.® drape.A device evaluation and a device history record review could not be performed.Device labeling, available in print and online, states: warnings 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 and 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.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 are v.A.C.® dressing general guidelines dressing changes wounds being treated with the 3m¿ v.A.C.® therapy system should be monitored on a regular basis.In a monitored, noninfected wound, v.A.C.® dressings should be changed every 48 - 72 hours but not less than three times per week, with frequency adjusted by the healthcare practitioner 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 taking into account local and systemic signs of infection.The dressing change intervals should be based on a continuing evaluation of wound condition and the patient's clinical presentation, rather than a fixed schedule.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) 2024, the following information was provided to kci by the patient's family member: patient was treated for a fungal infection allegedly due to the v.A.C.® drape while hospitalized for congestive heart failure.On (b)(6) 2024, the following information was provided to kci by the nurse: the patient was prescribed fluconazole oral antifungal for fungal infection to periwound.The nurse confirmed the patient responded well to the treatment and rash has resolved.The v.A.C.® dressing type and lot number were 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 ; 2102556738
• MDR Report Key: 18993422
• MDR Text Key: 338886418
• Report Number: 3009897021-2024-00017
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR
• Patient Sex: Female