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

Model Number CRA-SGP

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

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 05/18/2022

Event Type  Injury  

Event Description

A patient injury was reported during use of the grounding pad, 2 (two) small burns (smaller than a dime) were present on the patient's lower left extremity (lle).The burns were reportedly painful per the patient.The grounding pad was vertically placed on the left calf with the cord connection towards the patient¿s head.There were reportedly no error messages; however, as soon as the machine was turned on the patient complained of pain in their left leg.The defective grounding pad was immediately removed from the posterior lle and a new grounding pad applied to the right lower extremity (rle).Antibiotic ointment was prescribed by the physician, the outpatient was provided instructions for the care of the site.It was additionally noted that the patient was alive.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 15 jun 2022 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 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.

Manufacturer Narrative

The device history record for lot 202112141 was reviewed and the product was produced according to product specifications.The device was returned to the avanos failure analysis lab (fal).The fal received one used grounding pad inside opened packaging.The plug was examined: there were no cracks or breaks, the wiring did not exhibit any visible damage, the blue insulation was intact and the connection to the pad was secure with no visible damage.The root cause is undetermined.All information reasonably known as of 11 jul 2022 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 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.

Manufacturer Narrative

All information reasonably known as of 16 sep 2022 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 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: AVANOS GROUNDING PAD
• Type of Device: STANDARD RF CABLES & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): CONMED CORPORATION; 525 french rd; utica NY 13502
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14706466
• MDR Text Key: 294118786
• Report Number: 3011270181-2022-00044
• Device Sequence Number: 1
• Product Code: JOS
• UDI-Device Identifier: 20653405986581
• UDI-Public: 20653405986581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: CRA-SGP
• Device Catalogue Number: N/A
• Device Lot Number: 202112141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VALIUM
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: Black Or African American