MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. PREVENA¿ DRESSING; OMP

Model Number VACDSP

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

Patient Problem Fungal Infection (2419)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

The prevena¿ dressing lot number was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged fungal infection is related to the prevena¿ dressing.Multiple unsuccessful attempts were made for additional clinical and device information.It is unknown if and what medical or surgical intervention was required.Device labeling, available in print and online, states: warnings: infected wounds: as with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).Silver in the interface layer of prevena¿ dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric.If infection develops, prevena plus¿ therapy should be discontinued until the infection is treated.

Event Description

On (b)(6) 2022, the following information was reported to kci: the obstetrician stopped letting the patient take a shower and only allowed a sponge bath for a week allegedly due to yeast under the prevena¿ dressing.No additional information was provided.The prevena¿ dressing lot number was not provided and the device was not returned, therefore a device evaluation and device history record review could not be performed.

• Brand Name: PREVENA¿ DRESSING
• 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: 15059335
• MDR Text Key: 296211485
• Report Number: 3009897021-2022-00121
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2022
• 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