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

Model Number WNDPRV

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

Patient Problem Seroma (2069)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Age at time of event, date of birth: the patient ages were not provided.The article noted the mean age: 73.9 years, thus (b)(6) years was utilized.Sex: females and males were included in this study.Outcomes attributed to adverse event - other serious or important medical events: it is unknown if and what medical or surgical intervention was performed.Date of event: the date of the events was not provided.The article noted the data was retrospectively on patients with wound closures from july 2015 to june 2019, thus the date 01-jul-2015 was utilized.Other (code unspecified, device identifiers were not provided, and the devices were not returned for evaluation.Based on information provided, it cannot be determined that the alleged seromas are related to the prevena" incision management system.The article noted there was no statistical difference between the two groups in the rate of seroma formation.It also noted that most seromas were managed non-operatively with observation and this may not be clinically significant.It is unknown if and what medical or surgical intervention was performed.The device has not been demonstrated to be effective in reducing the incidence of surgical site infection and seroma in all surgical procedures and patient populations; therefore, the device may not be recommended for routine use to reduce the incidence of surgical site infection and seroma as per manufacture's indications for use.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.Device labeling, available in print and online, states: prevena" 125 and prevena plus" 125 therapy units manage the environment of closed surgical incision and is intended to aid in reducing the incidence of seroma; and in patient's at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in class i and class ii wounds.The device has not been demonstrated to be effective in reducing the incidence of surgical site infection and seroma in all surgical procedures and patient populations; therefore, the device may not be recommended for routine use to reduce the incidence of surgical site infection and seroma.Warnings: the therapy unit is a prescription medical device.Please read and follow the instructions in this guide so the product can perform properly while in use.

Event Description

On 23-jun-2021 the following information was received by kci after a review of journal article, laura j.Meiler, elsworth c.Beach, bhakti chavan, kristen j.Conrad-schnetz, jeffrey a.Stanley, nicole d.Ramon.Benefit of negative pressure dressings in vascular surgery patients with infra-inguinal 1 incisions after short-term followup assessing the benefit of incisional negative pressure 2 dressings in community-based vascular surgery patients with infra-inguinal incisions.J vasc surg.2021 may 18: s0741-5214(21)00738-2.Doi: 10.1016/j.Jvs.2021.04.058 noted the following: under table 3: 2 of 18 patients experienced femoral seromas.The article noted, "there was no statistical difference between the two groups in the rate of seroma formation.Within the vascular patient population there is increased risk of developing wound complications especially in infra-inguinal incisions.Discussion noted "most seromas were managed non-operatively with observation and this may not be clinically significant." no additional information was provided.The prevena" incision management system identifiers were not provided, therefore device evaluations and device history record reviews cannot be completed.

• Brand Name: PREVENA 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: 12204900
• MDR Text Key: 265882691
• Report Number: 3009897021-2021-00175
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDPRV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2021
• 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 Age: 74 YR