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

Model Number WNDPPL

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

Patient Problem Necrosis (1971)

Event Date 09/27/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided to kci by the physician: on (b)(6) 2022, the prevena plus¿ incision management system was applied post-operatively.On (b)(6) 2022, the device was removed at the end of therapy.Upon removal, it was noted that part of the epidermis had allegedly necrotized, and the physician believed this was due to the use of the prevena plus¿ incision management system as the necrosis was only on the surface.The necrotic tissue was treated with sharp debridement and an unspecified cream.No further information provided.The prevena plus¿ incision management system was discarded; therefore, a device evaluation could not be performed.A device history record review for the prevena plus¿ incision management system lot number a01292v009 was completed.All end release testing of product and packaging met specifications.

Manufacturer Narrative

The prevena plus¿ incision management system was discarded; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged necrosis requiring debridement and application of a cream is related to the prevena plus¿ incision management system.All end release testing of product and packaging met specifications.Device labeling, available in print and online, states: the prevena plus¿ incision management system will not be effective in addressing complications associated with: ischemia to the incision or incision areas, untreated or inadequately treated infection, inadequate hemostasis of the incision, cellulitis of the incision area.The prevena plus¿ incision management system should be used with caution in the following patients: patients with fragile skin surrounding the incision as they may experience skin or tissue damage upon removal of the prevena¿ dressing.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: 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: 15995620
• MDR Text Key: 305605155
• Report Number: 3009897021-2022-00180
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005365
• UDI-Public: 01008495540053651724083110A01292V009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2022

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
• Device Operator: Health Professional
• Device Model Number: WNDPPL
• Device Catalogue Number: PRE4001
• Device Lot Number: A01292V009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/16/2022
• 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): Required Intervention