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

Model Number VACDSP

Device Problem Failure to Seal (4070)

Patient Problem Fungal Infection (2419)

Event Date 10/26/2022

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 candidiasis rash to the periwound requiring medication is related to the v.A.C.® drape.The clinician noted that there were seal issues due to the patient's skin folds and size of the wound.Device labeling, available in print and online, states: precautions 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.Ensuring dressing integrity : it is recommended that a clinician or patient (in the home) visually check the dressing every two hours to ensure that the foam is firm and collapsed in the wound bed while therapy is active if not: -make sure the display screen reads therapy on.If not, press the therapy on/off button.-confirm the clamps are open and the tubing is not kinked.-identify air leaks by listening with a stethoscope or moving your hand around the edges of the dressing while applying light pressure.-if you find that the seal is broken and the v.A.C.® drape has become loose, trim away any loose or moist edges, ensure the skin is dry and then apply new drape strips.Note: if a leak source is identified, patch with additional drape to ensure seal integrity.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.If a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: -check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Wound infection call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever.Your wound is sore, red or swollen.Your skin itches or you have a rash or redness around the wound.The area around the wound feels very warm.You have pus or a bad smell coming from the wound.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) 2022, the following information was reported to kci by the wound care nurse: on (b)(6) 2022, v.A.C.® therapy was placed on hold allegedly due to a surrounding candidiasis rash to the periwound.The patient was allegedly having seal issues with the v.A.C.® drape "due to skin folds and size of the wound." a topical antifungal/steroid medication was ordered to be applied for fourteen days and an alternate dressing was placed.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.

• 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: 15846237
• MDR Text Key: 304173680
• Report Number: 3009897021-2022-00174
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• 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: 69 YR
• Patient Sex: Male