MAUDE Adverse Event Report: PREVENA RESTOR BELLA·FORM¿ DRESSING; OMP

Model Number WNDPPR

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

Patient Problems Cellulitis (1768); Failure of Implant (1924); Itching Sensation (1943); Blister (4537)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

The prevena restor bella·form¿ dressing identifier was not provided and the product was discarded.Based on the information provided, it cannot be determined that the alleged events are related to the prevena restor bella·form¿ dressing.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.The prevena restor bella·form¿ dressing was removed 5 days prior to the alleged infection and subsequent implant failure.The prevena restor bella·form¿ dressing lot number was not provided and the product was not returned; therefore, a device history review and a device evaluation could not be performed.The root cause could not be determined.Device labeling, available in print and online, states: warnings: allergic response: 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 prevena¿ dressings.If any signs of allergic reaction, irritation 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.The prevena restor¿ incision management system dressings, therapy unit and canister are disposable and are for single use only.Re-use of disposable components may result in wound contamination or infection.For maximum benefit the prevena restor¿ incision management system should be applied immediately post-surgery to clean surgically closed wounds.The prevena restor¿ incision management system will not be effective in addressing complications associated with: untreated or inadequately treated infection.Cellulitis of the incision area.

Event Description

On 17-aug-2021, the following information was provided to kci by the physician: the patient allegedly experienced a reaction from the prevena restor bella·form¿ dressing.The patient's skin was reportedly inflamed, bright red, and blistering.Prevena restor bella·form¿ dressing was removed on day 7 as the patient was reportedly sore and itchy.The patient was referred to dermatology.Subsequently, the patient was re-admitted on post-operative day 13 allegedly due to infection/cellulitis noted over the implant.The patient was taken back to theatre, and the reconstruction was lost.It was noted that the patient has previously used the prevena restor bella·form¿ dressing with no issues or complications.On 26-aug-2021, the following information was provided to kci by the physician: the prevena restor bella·form¿ incision management system allegedly contributed to the reaction and subsequent infection, mostly due to the adhesive from the prevena restor bella·form¿ dressing after day 7 which resulted in the deterioration at day 13.There was reportedly no improvement post removal of the prevena restor bella·form¿ incision management system at day 7, and the patient's wound allegedly got worse.Intervention was taken by dermatology on day 13 and the patient subsequently returned to the theatre and the implant was lost.There were no contributing factors provided.The prevena restor bella·form¿ dressing was disposed of and the product was not returned.On 27-aug-2021, the following information was reported to kci: on (b)(6) 2021, the prevena restor bella·form¿ dressing was applied.On (b)(6) 2021, 7 days post-operative, the patient allegedly experienced issues and the prevena restor bella·form¿ dressing was removed.The patient underwent surgery on (b)(6) 2021.On 31-aug-2021, the following information was reported to kci by the surgeon: the timescale was clarified as follows: on (b)(6) 2021, the prevena restor bella·form¿ dressing was applied.Patient exhibited a severe dressing reaction, and the dressing was removed on (b)(6) 2021 and high dose antihistamines were initiated.On (b)(6) 2021, dermatology opinion to start steroids for skin allergy and breakdown.On (b)(6) 2021, the patient was readmitted with infection.On (b)(6) 2021, the patient's implant/reconstruction was lost.

Manufacturer Narrative

Mdr-3009897021-2021-00228 submitted on 16-sep-2021 noted the following: d4 model #: vacdsp.Correction d4 model #: wndppr.Based on the correction provided, kci's assessment remains the same, it cannot be determined that the alleged events are related to the prevena restor bella·form¿ dressing.

• Brand Name: PREVENA RESTOR BELLA·FORM¿ DRESSING
• Type of Device: OMP
• MDR Report Key: 12484847
• MDR Text Key: 274490081
• Report Number: 3009897021-2021-00228
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K181507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDPPR
• Device Catalogue Number: PRE5321
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• 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): Hospitalization; Required Intervention