MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN RF PROBE; COOLED RF PROBES AND CANNULAS

Model Number UNKNOWN

Device Problem Peeled/Delaminated (1454)

Patient Problem Burn(s) (1757)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 27-dec-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

Event Description

It was reported the outer insulation of the introducer needle came off.The clinician stated that while performing a bilateral knee coolief procedure on a patient they noticed the insulation coming off of the device.After performing a lesion burn, the patient experienced a skin burn as a result of the insulation coming off the device.The clinician thought the insulation had come off when moving the green skin markers but could not be sure.Additional information received 18-dec-2019 stated the patient is being followed by the wound care clinic.The patient has a full-thickness burn with circular ulceration of about 1.5cm, currently without evidence of infection.

• Brand Name: UNKNOWN RF PROBE
• Type of Device: COOLED RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9530596
• MDR Text Key: 182628785
• Report Number: 8030647-2019-00111
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention