MAUDE Adverse Event Report: AVANOS MEDICAL INC. RF GROUNDING PAD DISPOSABLE WITH CORD; STANDARD RF CABLES & ACCESSORIES

Model Number	PMA-GP-BAY
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
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.All information reasonably known as of 15-feb-2019 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 comp (b)(4).
Event or Problem Description
It was reported the patient sustained a skin burn under the grounding pad area of the skin.The patient was diabetic.The patient had a left three level lumbar standard radio frequency ablation (sra) on (b)(6) 2019.The grounding pad was placed on the back of the upper left thigh.The patient was not hairy and the grounding pad adhesion appeared normal.The procedure proceeded without incident with both motor and sensory testing, no high impedances nor warnings on pain management generator (pmg).Six days after the procedure the patient went to the emergency room (er) with report of a burn at grounding pad site.The nurse reviewed the skin and described the skin as a full thickness circular wound the size of a dime.It is unknown what treatment was done in the er.No additional information was provided.

• Brand Name: RF GROUNDING PAD DISPOSABLE WITH CORD
• Common Device Name: STANDARD RF CABLES & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8345777
• Report Number: 3011270181-2019-00006
• Device Sequence Number: 16623275
• Product Code: JOS
• UDI-Device Identifier: 20680651986065
• UDI-Public: 20680651986065
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PMA-GP-BAY
• Device Catalogue Number: 109860601
• Device Lot Number: UNKNOWN
• 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: 01/30/2019
• Initial Report FDA Received Date: 02/15/2019
• Patient Sequence Number: 1
• Patient Weight: 69