MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number WNDARM

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

Patient Problems Fungal Infection (2419); Tissue Breakdown (2681)

Event Date 08/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was reported to kci by the patient: the patient went to see the physician on (b)(6) 2022 and v.A.C.® therapy was allegedly removed due to skin breakdown.On (b)(6) 2022, the following information was reported to kci by the nurse: v.A.C.® therapy is on hold due to alleged skin breakdown and fungal infection and is being treated with nystatin powder.No additional information was provided.On (b)(6) 2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.On (b)(6)2022, the device was placed with the patient.On (b)(6) 2022, the device was tested per quality control procedure by the kci service center and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged skin breakdown and fungal infection requiring antifungal medication is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient reportedly was on oral antibiotic therapy which may have contributed to the event.The device passed quality control checks before and after patient placement.Device labeling, available in print and online, states: wound infection call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever your wound is sore, red or swollen your skin itches or you have a rash or redness around the wound the area around the wound feels very warm you have pus or a bad smell coming from the wound infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as wound conditions, treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.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).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.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: ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING 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: 15344460
• MDR Text Key: 299151521
• Report Number: 3009897021-2022-00140
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CELEBREX 200 MG; EXCEDRIN MIGRAINE 25-250-65MG; FLONASE 50 MCG/ACT; LINEZOLID; MULTIPLE VITAMIN 1 TAB; NORVASC 5 MG; PROBIOTIC FORMULA 1250 MG; TYLENOL 650 MG; VASOTEC 20 MG; VITAMIN C 1000 MG; VITAMIN D 1000 MG; ZOSYN
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 108 KG