MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM; OMP

Model Number WNDPPL

Device Problems Break (1069); Disconnection (1171)

Patient Problem Unspecified Infection (1930)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

The occurrence date for the prior infections is unknown.Therefore, the date of the most recent alleged infection was utilized.The prevena plus¿ system lot number was not provided and the device was not returned; therefore a device evaluation and device history record review could not be performed.Based on the information provided, it cannot be determined that the alleged infections are related to the prevena plus¿ incision management system.Additionally, it is unknown if and what medical or surgical intervention was required to mitigate the alleged events.Multiple unsuccessful attempts were made to obtain additional clinical and device information.Device labeling, available in print and online, states: warnings: infected wounds: 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).Silver in the interface layer of prevena¿ dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric.If infection develops, prevena plus¿ therapy should be discontinued until the infection is treated.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.

Event Description

On (b)(6) 2022, the following information was provided to kci by the patient: on (b)(6) 2022, the patient underwent knee replacement surgery to the left knee and a prevena plus¿ incision management system was placed.The patient has had four prior surgeries and a prevena plus¿ incision management system has been placed after each one.The patient allegedly developed an infection after each surgery due to the lanyard strap clip breaking, which then caused the units to fall.The force of the fall disconnected the tubing from the canister, causing a breach in the seal.No additional information was provided.The prevena plus¿ system lot number was not provided and the device was not returned, therefore a device evaluation and device history record review could not be performed.

• Brand Name: PREVENA PLUS¿ INCISION MANAGEMENT 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: 15728164
• MDR Text Key: 303045783
• Report Number: 3009897021-2022-00169
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDPPL
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male