MAUDE Adverse Event Report: AVANOS MEDICAL INC. COOLIEF COOLED RADIOFREQUENCY PAIN GENERATOR, VERS-4; PAIN MANAGEMENT GENERATORS & ACCESSORIES

Model Number PMG-ADVANCED

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The actual device is reported to be available but has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 03-apr-2024 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.H3 other text: device not returned.

Event Description

It was reported the "machine was not able to achieve burning temperature, with impedance rising from 500 to 2200 ohms prior to self-terminating after approximately 40 sec attempted further 2 attempts at rf at above settings with same issue pulled back blanket to ensure diathermy pad was well adhered to the leg in case that was the issue and noted charring.Immediately turned off the machine and instructed [the physician] to terminate the procedure." the patient's injuries noted two points of burn on the corresponding to diagonal points of the diathermy pad - two burns on thigh with charring."unclear if arced over skin or through muscle.Medical treatment was provided secondary to burns to thighs.The clinicians "impression is that there was poor contact of the skin adhesive to the skin due to interference from hair." medical treatment "was provided secondary to burns to thighs.".

• Brand Name: COOLIEF COOLED RADIOFREQUENCY PAIN GENERATOR, VERS-4
• Type of Device: PAIN MANAGEMENT GENERATORS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): STELLARTECH RESEARCH CORP.; 560 cottonwood dr; milpitas CA 95035
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19037430
• MDR Text Key: 339321081
• Report Number: 3011270181-2024-00043
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10680651422979
• UDI-Public: 10680651422979
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K163461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PMG-ADVANCED
• Device Catalogue Number: N/A
• Device Lot Number: ST8003-008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 71 KG