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 11/22/2023

Event Type  Injury  

Event Description

On 24-nov-2023, the following information was provided to kci by the patient: he had a follow up appointment with the physician on (b)(6) 2023.The physician noted a buildup of yeast surrounding the wound due to the wound's location.V.A.C.® therapy was discontinued for a few days due to a possible yeast infection.He has been on antibiotics since the start of v.A.C.® therapy.On 14-dec-2023, the following information was provided to kci by the nurse: the patient was treated with nystatin cream for a yeast rash to the peri-wound.The rash was allegedly due to the v.A.C.® drape and the location of the wound.The patient's wound has improved and healed to the point where v.A.C.® therapy is no longer needed.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.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged yeast 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: 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.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.

• 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 ; 2102556436
• MDR Report Key: 18351094
• MDR Text Key: 330815770
• Report Number: 3009897021-2023-00077
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2023
• 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: ATORVASTATIN 20MG PO QD; ESCITALOPRAM 20MP PO QD; LANTUS 20 UNITS EVERY NIGHT; LOSARTAN 50MG PO QD; METFORMIN 1000MG 1 TABLET PO BID; NOVALOG FLEXPEN 100UNITS/ML PER SLIDING SCALE SQ; SENOKOT 8.6-50 MG 2 TABS PO BID
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male