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

Lot Number ASKU

Device Problem Leak/Splash (1354)

Patient Problem Fungal Infection (2419)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

The v.A.C.® dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.Based on information provided, kci could not determine that the alleged yeast infection is related to the v.A.C.® drape.Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected 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, and cellulitis of the incision area.

Event Description

On (b)(6) 2022, the following information was reported to kci by the patient: on (b)(6) 2022, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to the v.A.C.® drape leaking and caused a fungal infection.On (b)(6) 2022 the following information was provided to kci by the wound clinic nurse: the patient had issues with the v.A.C.® drape gathering fluid and leaking, which caused the patient to get a fungal rash/infection around the wound.The physician placed v.A.C.® therapy on hold until the next appointment on (b)(6) 2022.The fungal infection was treated with anti-fungal powder and an alternative dressing.The v.A.C.® dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation 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: stephen jackson ; 6203 farinon dr; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 13519469
• MDR Text Key: 290160063
• Report Number: 3009897021-2022-00026
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2022
• 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
• Treatment: AMLODIPINE 5MG, 1 TAB DAILY
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female