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

Model Number WNDULT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nervous System Injury (2689)

Event Date 05/05/2022

Event Type  Injury  

Event Description

The following information was received by kci after review of journal article: "tension pneumocephalus associated with negative pressure wound therapy with instillation and dwell time for methicillin-resistant staphylococcus aureus infection after spinal deformity surgery", which noted the following under section results: "on the 29th day after the start of npwti-d, the patient experienced sudden headache and neck pain while standing, and head computed tomography led to the diagnosis of symptomatic pneumoencephalopathy.Npwti-d was discontinued, and when surgery was performed to close the wound, dural injury was found, which was not present at the time of the initial surgery, and dural repair was performed.After 2 weeks of bed rest, the patient's pneumoencephalopathy improved.Three years have passed since the surgery, and no recurrence of cerebrospinal fluid leakage or infection has been observed." no additional information was provided.The v.A.C.Ulta¿ therapy system product identifier was not available; therefore, a device evaluation could not be performed.

Manufacturer Narrative

Date of event: the specific date of event is unknown.The article was submitted on 05-may-2022, therefore this date was used.Based on the information available, it cannot be determined that the alleged pneumoencephalopathy and dural injury were related to the v.A.C.Ulta¿ therapy system.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.No device identifier was available, therefore, a device evaluation could not be performed.Device labeling, available in print and online, states: keep v.A.C.® therapy and v.A.C.Veraflo¿ therapy on: never leave a v.A.C.® dressing or v.A.C.Veraflo¿ therapy dressing in place without active v.A.C.® therapy or v.A.C.Veraflo¿ therapy for more than two hours.If therapy is off for more than two hours, remove the old dressing and irrigate the wound.Either apply a new v.A.C.® dressing or v.A.C.Veraflo¿ therapy dressing from an unopened sterile package and restart therapy; or apply an alternative dressing at the direction of the treating clinician.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 and v.A.C.Veraflo¿ therapy parameters (for the v.A.C.Ulta¿ therapy system).Refer to dressing application instructions (found in v.A.C.® dressing and v.A.C.Veraflo¿ 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 a physician immediately to determine if v.A.C.® therapy or v.A.C.Veraflo¿ therapy should be discontinued.Protect tendons, ligaments and nerves: tendons, ligaments and nerves should be protected to avoid direct contact with v.A.C.® foam dressings.These structures may be covered with natural tissue, meshed non-adherent material or bio-engineered tissue to help minimize risk of desiccation or injury.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.

• Brand Name: V.A.C.ULTA¿ THERAPY SYSTEM
• 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: 15597483
• MDR Text Key: 301681148
• Report Number: 3009897021-2022-00160
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDULT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female