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 Problems Necrosis (1971); Contact Dermatitis (4546)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Device identifier was not provided and the device was not returned for evaluation.Based on information provided, it cannot be determined that the alleged blistering and necrosis requiring debridement are related to the prevena¿ incision management system.The nurse initially requested follow up to determine the cause of an incident.It is unknown if the patient had a pre-existing allergy to tapes or adhesives.Device labeling, available in print states: the prevena¿ incision management system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area.Untreated or inadequately treated infection.Inadequate hemostasis of the incision.Cellulitis of the incision area.The prevena¿ 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¿ incision dressing.Contraindications: sensitivity to silver.Warnings: allergic reaction.The prevena dressing has an acrylic adhesive coating and a skin interface layer with silver, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives or silver.If a patient has a known allergy or hypersensitivity to these materials, do not use the prevena therapy system.If any signs of allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus, patient should consult a physician immediately.If bronchospasm or more serious signs of allergic reaction appear, the patient should turn off the therapy and seek immediate emergency medical assistance.

Event Description

On (b)(6) 2021, the following information was provided to kci by the nurse: the patient underwent an abdominoplasty on (b)(6) 2021, and the prevena¿ incision management system was removed on (b)(6) 2021.Progress note says "prevena removed and abdomen is soaking wet at midline.There is noted midline compromise 5cm x 12cm.18-gauge needle punctured several aspects of compromise with no blood return." patient was then started on dilute nitro placing morning and night and covering with a telfa¿ dressing [non-kci dressing].At the time of removal there was no drainage in canister.Today she changed to wet to damp dressings until we debride this area wednesday.On (b)(6) 2021, the following information was provided to kci: the nurse requested follow up to determine the cause of an incident described as a wound found under a prevena¿ dressing that was applied post operatively.The prevena¿ incision management system and the prevena¿ dressing were disposed of seven days post operatively.A kci wound v.A.C.® has been ordered and a planned debridement with wound v.A.C.® application is scheduled for (b)(6) 2021.On (b)(6) 20201, an image was provided that exhibited approximately 5cm x 12cm area of black tissue with redness extending inferior from the incision line.On (b)(6) 2021, the following information was provided to kci by the nurse: on (b)(6) 2021, the patient underwent surgery and the prevena¿ incision management system was placed on the patient.On (b)(6) 2021, blistering on the incision line that extended inferior to the patient's umbilicus was observed upon removal of the prevena¿ incision management system.The blisters allegedly "opened up," and the dressing was reportedly wet, but no leakage was observed.The patient underwent a debridement on (b)(6) 2021 for the open blisters.It was noted that "some" of the blistering was necrotic tissue.The patient was subsequently placed on an activ.A.C.¿ therapy system.The prevena¿ incision management system and the prevena¿ dressing were disposed of seven days post operatively.The device identifier was not provided and the product was not returned, therefore a device history record review and device evaluation could not 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 ; 2102556328
• MDR Report Key: 11777173
• MDR Text Key: 264472549
• Report Number: 3009897021-2021-00103
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDPRV
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• 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): Required Intervention