ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM WNDARM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for ACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM WNDARM manufactured by Kinetic Concepts, Inc..

Event Text Entries

[188564614] Based on information provided, it cannot be determined that the alleged rash / yeast infection is related to the activ. A. C.? Ion progress? Remote therapy monitoring system. It is unknown if and what medical or surgical intervention was performed. Kci has made multiple unsuccessful attempts to obtain additional clinical information. Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected 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. Precautions the v. A. C.? Therapy 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.
Patient Sequence No: 1, Text Type: N, H10


[188564615] On 26-feb-2020, the following information was reported to kci by the patient: on (b)(6) 2020, the activ. A. C.? Ion progress? Remote therapy monitoring system was placed on hold and the patient was placed on an alternate dressing allegedly due to a rash / yeast infection around the wound. The patient stated this is an ongoing issue. No additional information available. A device evaluation for activ. A. C.? Ion progress? Remote therapy monitoring system is pending completion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009897021-2020-00129
MDR Report Key9890925
Report SourceCONSUMER
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-23
Date Mfgr Received2020-02-26
Device Manufacturer Date2018-11-27
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. STEVEN JACKSON
Manufacturer Street6203 FARINON DRIVE
Manufacturer CitySAN ANTONIO, TX
Manufacturer CountryUS
Manufacturer Phone2556438
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIV.A.C.? ION PROGRESS? REMOTE THERAPY MONITORING SYSTEM
Generic NameOMP
Product CodeOMP
Date Received2020-03-27
Returned To Mfg2020-03-04
Model NumberWNDARM
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKINETIC CONCEPTS, INC.
Manufacturer Address6203 FARINON DRIVE SAN ANTONIO, TX US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-27

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