MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. FREEDOM THERAPY SYSTEM; OMP

Model Number	WNDFRE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device: lot number 5453875v005: (b)(4).Based on information provided, it cannot be determined that the alleged infection is related to the v.A.C.Freedom¿ therapy system.It is unknown if either medical or surgical intervention or antibiotic therapy was required.Kci has made several attempts to gather additional information, but there has been no response.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, treatment goals and instillation therapy parameters (for the v.A.C.Instill® therapy system).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 (b)(6) 2019, the following information was reported to kci by the patient: the patient allegedly acquired an infection while on the v.A.C.Freedom¿ therapy system.No additional information is available.A device evaluation of (b)(4), and a device history review of lot number 5453875v005 are currently pending completion.
Additional Manufacturer Narrative
Based on the additional information obtained regarding the device history review and device evaluation, kci's assessment remains the same; it cannot be determined that the alleged infection is related to the v.A.C.Freedom¿ therapy system.
Event or Problem Description
A device history review of lot number 5453875v005 did not identify any nonconformances or deviations in the manufacturing of this lot.All end release testing of product and packaging performance met specifications.On 20-nov-2018, the device was tested per quality control procedure by kci field service, and the unit passed the quality control checks and met specifications.On (b)(6)2018, the device was placed with the patient.On 12-feb-2019, the device was tested per quality control procedure by kci quality engineering and the unit passed the quality control checks and met specifications.

• Brand Name: V.A.C. FREEDOM THERAPY SYSTEM
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 8289842
• Report Number: 3009897021-2019-00011
• Device Sequence Number: 11240808
• Product Code: OMP
• UDI-Device Identifier: 00849554006539
• UDI-Public: 0100849554006539
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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 Model Number: WNDFRE
• Device Lot Number: 5453875V005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMBIEN (DOSAGE & FREQUENCY UNKNOWN); AMITRIPTYLINE 25MG DAILY; AMLODIOPINE 5 MG, 1 TAB DAILY; ATORVASTATIN 10 MG, 1 TAB ONCE A DAY; CYCLOBENZAPRINE 5 MG, 1 TAB 3 TIMES A DAY; GABAPENTIN 300 MG, 3 CAPS EVERY 6 HOURS; RIVAROXABAN 20 MG, 1 TAB EVERY 24 HOURS; XARELLTO 20 MG (FREQUENCY IS UNKNOWN); AMBIEN (DOSAGE & FREQUENCY UNKNOWN); AMITRIPTYLINE 25MG DAILY; AMLODIOPINE 5 MG, 1 TAB DAILY; ATORVASTATIN 10 MG, 1 TAB ONCE A DAY; CYCLOBENZAPRINE 5 MG, 1 TAB 3 TIMES A DAY; GABAPENTIN 300 MG, 3 CAPS EVERY 6 HOURS; RIVAROXABAN 20 MG, 1 TAB EVERY 24 HOURS; XARELLTO 20 MG (FREQUENCY IS UNKNOWN)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 73