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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Numbness (2415); No Code Available (3191)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Root cause could not be determined.All information reasonably known as of (b)(6) 2020 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.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 Description

It was reported that the patient underwent a cooled radiofrequency ablation procedure on (b)(6) 2020.Patient has previously undergone pt [physical therapy], blocks, epidurals, and standard rf [radiofrequency ablation] for treatment of "thoracic ridiculopathy." patient reports that he is healthy except for back problems and ibs [irritable bowel syndrome].He underwent cooled rf--right-sided t9-l1.Patient was asleep for procedure with the use of versed and propofol.Patient reports that since waking up from the procedure, he has experienced dermal numbness and deeper burning sensation from l1-s1, rotating around from spine to right side, including flank.He has also experienced loss of bowel sensation warning him of need for bm [bowel movement], requiring him to run to the bathroom.Patient states that when he felt this numbness and burning the day of the procedure, he saw his physical therapist the same afternoon who confirmed large area of skin numbness and location of nerves he thought were involved.Patient notified the physician.Patient states that doctor told him he would be fully anesthetized during the procedure because she "didn't need to do any motor testing prior to the ablation so his participation in the procedure was not necessary." symptoms have not improved since day of procedure.Additional information received 10-feb-2020 from the patient indicated he has had no improvement in symptoms and the radiculopathy in thoracic spine returned to what was experienced preoperatively.The patient stated "i essentially have new pain symptoms from the complication related to the procedure since all new symptoms i have experienced started on (b)(6) 2020 when [physician] performed the procedure.".

• Brand Name: UNKNOWN COOLED RF PROBES AND CANNULAS
• 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: 9694819
• MDR Text Key: 192403984
• Report Number: 8030647-2020-00012
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 82