MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC DUAL PLATE 9FT CORD; RETURN ELECTRODE DUAL PLATE WITH CORD

Model Number	0855CN
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post-op to the unknown procedure that after the procedure the grounding pad was removed.The registered nurse noted skin irritation.Patient eventually had noticeable bruising and redness.The skin was still intake and pain free.The effective area was on the outer side and roughly six inches in length.Unknown of the current condition of the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/13/2023.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The dhr review is confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: is this a skin irritation a chemical or thermal reaction? or it is a burn? if yes for a burn, could you please confirm what is the severity of the burn? (please see degrees of burns below and choose one).O first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.O second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.O third degree burn the burn site looks deep, whitening or blackened and charred -what medical intervention was used to treat the skin irritation? (such as salve or stitches) -besides the skin lesion, did the patient experience any adverse consequence due to the issue? -are there any anticipated long-term effects from the skin lesion or burn? - what is the current status of the affected (patient or user)? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/15/2023.Maude report number : 1721194-2023-00007.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/2/2023.Additional information was requested, and the following was obtained: if yes for a burn, could you please confirm what is the severity of the burn? (please see degrees of burns below and choose one).N/a.What medical intervention was used to treat the skin irritation? (such as salve or stitches) n/a.Besides the skin lesion, did the patient experience any adverse consequence due to the issue? n/a.Are there any anticipated long-term effects from the skin lesion or burn? - n/a.What is the current status of the affected (patient or user)? - n/a.

• Brand Name: RTN ELEC DUAL PLATE 9FT CORD
• Common Device Name: RETURN ELECTRODE DUAL PLATE WITH CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16157716
• Report Number: 1721194-2023-00007
• Device Sequence Number: 15330269
• Product Code: GEI
• UDI-Device Identifier: 10614559104613
• UDI-Public: 10614559104613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 0855CN
• Device Catalogue Number: 0855CN
• Device Lot Number: 2012129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/13/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/02/2023; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown