MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. GRANUFOAM DRESSING; OMP

Model Number VACDSP

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fungal Infection (2419)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Based on the information provided, it could not be determined that the alleged yeast infection is related to the v.A.C.® granufoam¿ dressing.The device history record review of the v.A.C.® granufoam¿ dressing met specifications.Device labeling, available in print and online, states: 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.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-jun-2021, the following information was reported to kci by the patient: the patient stated that the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed on (b)(6) 2021 at the wound care center due to irritation.The patient stated that the doctor wanted the v.A.C.® to remain off for a day.The v.A.C.® was reapplied on (b)(6) 2021.On 08-jul-2021, the following information was received by kci via the medical investigation questionnaire: on (b)(6) 2021, when the dressing was removed, visual assessment of wound revealed that yeast was present around the wound from alleged leaking v.A.C.® granufoam¿ dressing and physician left v.A.C.® off to help clear the yeast.On 08-jul-2021, the following information was received by kci after a review of the physician's orders dated (b)(6) 2021: use lotrisone to periwound yeast two times per week for one week.Home health is to reapply v.A.C.® on (b)(6) 2021.On 08-jul-2021, the following information was received by kci after a review of the wound care center progress note dated (b)(6) 2021: the ulcer is improved, however, there is a good bit of excoriation and probable found fungi around the area.Periwound assessment: erythematous, excoriated, rash and scar tissue.The v.A.C.® therapy was discontinued due to the excoriation and it is not needed.An alternative dressing was ordered daily for one week with continuation of lotrisone cream application with dressing changes.On 08-jul-2021, the following information was received by kci after a review of the wound care center progress note dated (b)(6) 2021: periwound assessment: dry, rash, scaly and scar tissue.The surrounding candidiasis will be treated with diflucan 100 mg orally once plus one refill.Diflucan powder was ordered for application to periwound yeast daily for one week.On 08-jul-2021, the following information was received by kci after a review of the wound care center progress note dated (b)(6) 2021: periwound assessment: dry and scar tissue.Diflucan powder with skin prep spray/paste was ordered daily for an additional four days.A device history record review for the v.A.C.® granufoam¿ dressing lot number 8993888v009 was completed.All end release testing of the product and packaging met specifications.

• Brand Name: V.A.C. GRANUFOAM DRESSING
• 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: 12285097
• MDR Text Key: 265600088
• Report Number: 3009897021-2021-00191
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 010084955400209817240131108993888V009
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 8993888V009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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: 70 YR
• Patient Weight: 75