MAUDE Adverse Event Report: AVANOS MEDICAL INC. COOLED RADIOFREQUENCY KIT ADVANCED; CRPA-COOLIEF RF PROBES ADVANCED

Model Number	CRKA-17-50-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The lot number was not provided by the customer.All information reasonably known as of 04-mar-2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported "an infection occurred in a patient who was treated with coolief." the infection site was at the medial aspect above the patient's right knee.The coolief treatment date was (b)(6) 2025.The patient began experiencing pain on (b)(6) 2026.At the visit on (b)(6) 2026, the condition was diagnosed as an infection.It is unclear whether the symptoms are due to a bacterial infection or an exacerbation of inflammation caused by the ablation procedure.However, as the symptoms occurred at the treatment site, it is presumed that the condition was diagnosed as an infection.Additional information received 03-mar-2026 stating treatment for the infection included the administration of intravenous (iv) medication therapy.Infusion therapy was administered.The treatment is ongoing.The current condition is under continued follow-up.No medical intervention other than iv infusion therapy was required.

• Brand Name: COOLED RADIOFREQUENCY KIT ADVANCED
• Common Device Name: CRPA-COOLIEF RF PROBES ADVANCED
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24520802
• Report Number: 2026095-2026-00011
• Device Sequence Number: 9724241
• Product Code: GXI
• UDI-Device Identifier: 00193493478811
• UDI-Public: (01)00193493478811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CRKA-17-50-4
• Device Catalogue Number: CRKA-17-50-4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female