MAUDE Adverse Event Report: AVANOS MEDICAL INC. COOLIEF COOLED RF ADVANCED-R GENERATOR; CRG - COOLIEF RADIOFREQUENCY GENERATOR

Model Number	CRG-ADVANCED-R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Muscle Weakness/Atrophy (1967); Pain (1994); Numbness (2415); Osteomyelitis (4533)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.Prior to distribution, each unit must meet 100% of performance, tested for safety, performance, and function prior to distribution.All information reasonably known as of 16 mar 2021 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 complaint database and identified as (b)(4).
Event or Problem Description
It was reported that a coolief procedure was performed on a patient, where two lesions were created for the treatment of hip pain.During the procedure, the patient was "uncomfortable and sweating somewhat." a few days later, the patient started experiencing pain, numbness, and weakness in the right leg, and a temperature of 99 degrees fahrenheit.The patient visited a physician who "prescribed medications." after a few weeks the pain had not resolved, so the patient visited the emergency room and received a mri."the mri result showed osteomyelitis at the femoral joint.Patient then had surgery for debridement of the affected joint.During surgery there were no visible signs of drainage or infection.A culture was taken for labs and showed skin staphylococcus.The patient was then prescribed antibiotics for 6 weeks.Previous to the coolief procedure the patient had an interarticular steroid injection to the joint of the affected hip.His hip pain had increased prior to the coolief procedure.".

• Brand Name: COOLIEF COOLED RF ADVANCED-R GENERATOR
• Common Device Name: CRG - COOLIEF RADIOFREQUENCY GENERATOR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11504093
• Report Number: 3011270181-2021-00015
• Device Sequence Number: 3984614
• Product Code: GXD
• UDI-Device Identifier: 00193493473038
• UDI-Public: 00193493473038
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: CRG-ADVANCED-R
• Device Catalogue Number: N/A
• Device Lot Number: STZ20114-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention