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

Model Number	VACDSP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated my mfr: the v.A.C.® drape was not returned; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged yeast infection is related to the v.A.C.® drape.All end release testing of the product and packaging met specifications.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.Cellulitis of the incision area.
Event or Problem Description
On 25-feb-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 skin irritation, pain and patient developed a fungus around the wound due to moisture.Patient using a fungal powder and had a follow up with the vascular surgeon on (b)(6) 2022.The activ.A.C.¿ ion progress¿ remote therapy monitoring system will be on hold for 2 weeks.On (b)(6) 2022, the following information was reported to kci by the nurse: on (b)(6) 2022, the nurse stated patient had some redness and irritation under the v.A.C.® drape.The physician did ordered nystatin powder to treat the fungal infection caused by moisture under the v.A.C.® drape.On (b)(6) 2022, a device history record review for v.A.C.® granufoam¿ dressing lot number 9190886v009 and associated v.A.C.® drape was completed.All end release testing of the product and packaging met specifications.
Event or Problem Description
On 24-feb-2022, the following information was reported to kci by the patient: on 21-feb-2022, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to skin irritation, pain and patient developed a fungus around the wound due to moisture.Patient using a fungal powder and had a follow up with the vascular surgeon on (b)(6) 2022.The activ.A.C.¿ ion progress¿ remote therapy monitoring system will be on hold for 2 weeks.On 23-mar-2022, a device history record review for v.A.C.® granufoam¿ dressing lot number 9138894v009 and associated v.A.C.® drape was completed.All end release testing of the product and packaging met specifications.
Additional Manufacturer Narrative
Mdr-3009897021-2022-00064 submitted on 24-mar-2022 noted the following: section b5 describe event or problem: on 25-feb-2022, the following information was reported to kci by the patient: on 23-mar-2022, a device history record review for v.A.C.® granufoam¿ dressing lot number 9190886v009; section d4 lot#: 9190886v009; section d4 unique identifier (udi) #: (b)(4).Section b5 describe event or problem: on 24-feb-2022, the following information was reported to kci by the patient: on 23-mar-2022, a device history record review for v.A.C.® granufoam¿ dressing lot number 9138894v009; section d4 lot#: 9138894v009; section d4 unique identifier (udi) #: (b)(4).

• Brand Name: V.A.C.® DRAPE
• Common Device Name: 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: 13891953
• Report Number: 3009897021-2022-00064
• Device Sequence Number: 12325110
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 010084955400209817240331109138894V009
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K133276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 9138894V009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN 325MG TAB 2 TABS PO EVERY 6 HRS PRN.; ASPIRIN 325MG EC TAB, 1 TAB PO DAILY.; CLOPIDOGREL 75MG TAB, 1 TAB PO DAILY.; DOCUSATE SODIUM 100MG CAPSULE 1 CAPSULE EVERY MORN.; DULAGLUTIDE 3MG/0.5ML INJECTION, INJECT 0.5ML UNDE.; EVOLOCUMAB 140MG/ML SYRINGE, INJECT 140MG UNDER TH.; FAMOTIDINE 20MG TAB, 1 TAB PO EVERY MORNING AND EV.; FENOFIBRATE 48MG TAB, 1 TAB EVERY MORNING AND EVER.; IBUPROFEN 600MG TABS, 1 TAB PO EVERY 6 HRS AS NEED.; LISINOPRIL 10MG TAB, 1 TAB PO DAILY.; MELATONIN 10MG CAPSULE, 1 CAPSULE PO AT BEDTIME AS.; METFORMIN 1000MG TAB, 1 TAB PO WITH BREAKFAST AND.; METOPROLOL ER 25MG 24HR TAB, 1 TAB PO DAILY.; MULTIVITAMIN CAPSULE, 1 CAPSULE PO DAILY.; OMEGA 3 FATTY ACIDS/ FISH OIL 300-1,000MG CAPSULE.; PSYLLIUM 3.4 GRAM PACKET, 1 PACKET PO DAILY.; SILDENAFIL 20MG TAB, 5 TABS 1 HR PRIOR TO SEXUAL A.; TRAZODONE 100MG TAB, 1 TAB PO AT BEDTIME FOR 90 DA.; TRIAMCINOLONE 0.1% OINTMENT, APPLY TOPICALLY TO EL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male