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 04/18/2022

Event Type  Injury  

Manufacturer Narrative

The prevena plus¿ incision management system lot number was not provided and was discarded; 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 necrotic tissue requiring debridement are related to the prevena plus¿ incision management system.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.

Event Description

On 17-may-2022, the following information was provided to kci by the physician: the patient's left hip wound allegedly had 50% superficial necrosis upon dressing removal and delayed wound healing.As a result, the prevena plus¿ incision management system was discontinued, and more advanced wound care was allegedly required.On 20-may-2022, the following information was provided to kci: on (b)(6) 2022, the prevena plus¿ incision management system was placed on the patient and was discontinued and discarded on day 12 when the superficial necrotic tissue was discovered.The reason for the event is unknown.On 06-jun-2022, the following information was provided to kci: the physician is continuing to use prevena¿ therapy and has no further issues.The reason for this occurrence is not conclusive.The patient's incision has healed nicely, and no further care was needed.On 09-jun-2022, the following information was provided to kci: the patient's wound was debrided at the bedside to resolve.No additional information was provided.The prevena plus¿ incision management system lot number was not provided and was discarded; 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: 14680169
• MDR Text Key: 294908363
• Report Number: 3009897021-2022-00117
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2022

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: PRE4010
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/13/2022
• 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