MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC DUAL PLATE 15FT CORD; RETURN ELECTRODE DUAL PLATE 15 FT CORD

Catalog Number	0855CL
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The following information was requested but unavailable.
Event or Problem Description
It was reported that during an atrial fibrillation ablation procedure a second-degree patient burn occurred.Following the procedure, a second-degree burn was located at the site of the disposable patient return electrode.

• Brand Name: RTN ELEC DUAL PLATE 15FT CORD
• Common Device Name: RETURN ELECTRODE DUAL PLATE 15 FT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8318585
• Report Number: 1721194-2019-00079
• Device Sequence Number: 19255547
• Product Code: GEI
• UDI-Device Identifier: 10614559104019
• UDI-Public: 10614559104019
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0855CL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other