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	Grounding Malfunction (1271)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional 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 01-oct-2018.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).Device not returned.
Event or Problem Description
It was reported that during the second burn the pain management generator (pmg) gave a temperature error message.Additional information received (b)(6) 2018 stated the first round of ablation was successful.The location of the grounding pad was the right flank.The procedure was a lumbar radio frequency (rf) ablation.An unknown error message was noted.The physician was able to continue with procedure.During the second burn, the pmg gave a temperature error message, exact message unknown.Staff heard a "crackling" noise and a burn was noticed under patient's right flank.The grounding pad was removed from the right flank and replaced with a new grounding pad.A second grounding pad was placed on the upper thigh and the procedure was completed without issue.A wound care nurse was consulted for the burn.It was unknown what severity or if treatment was required.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 2018.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.
Additional Manufacturer Narrative
The sample was evaluated.No issue was found with the complaint ground pad.The failure was not confirmed.No root cause was identified.All information reasonably known as of (b)(6) 2018.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.

• 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: 7928124
• Report Number: 3011270181-2018-00044
• Device Sequence Number: 1914543
• Product Code: JOS
• UDI-Device Identifier: 20680651986065
• UDI-Public: 20680651986065
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 12/06/2018

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?: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/26/2018; 12/06/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/16/2018; 12/28/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention