MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. GRANUFOAM DRESSING; 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	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The v.A.C.® granufoam¿ dressing was not returned; therefore, a 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.® 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 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 21-jul-2021, the following information was reported to kci by the patient: on (b)(6) 2021 the patient is off the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly due to a yeast infection with redness and burning to the periwound where the v.A.C.® drape was placed.The physician has tried different treatments, including nystatin and diflucan, that were not effective.The physician decided to place an alternate dressing since the patient's wound has been progressing well.On 10-aug-2021, the following information was provided to kci by the healthcare provider via the medical questionnaire: the patient allegedly experienced a yeast infection due to moisture accumulation, and the physician reportedly tried different treatments, including antifungal powder, that were ineffective.No additional information was provided.A device history record review for v.A.C.® granufoam¿ dressing lot number 9054887v009 was completed.All end release testing of the product and packaging met specifications.The v.A.C.® granufoam¿ dressing was discarded; therefore, a device evaluation could not be performed.

• Brand Name: V.A.C. GRANUFOAM DRESSING
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 12339884
• Report Number: 3009897021-2021-00190
• Device Sequence Number: 5087610
• Product Code: OMP
• UDI-Device Identifier: 00849554002098
• UDI-Public: 010084955400209817240228109054887V009
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2021

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: 02/28/2024
• Device Model Number: VACDSP
• Device Catalogue Number: M8275052
• Device Lot Number: 9054887V009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR