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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information was requested and the following was received: the status of the pt is she was sent home that day and is fine.
Event or Problem Description
It was reported that during a plastic surgery, when the pad was removed from the patient, there was some redness/bruising and swelling.There were no patient consequences.No additional information is available at this time.

• Brand Name: RTN ELEC DUAL PLATE 9FT CORD
• Common Device Name: RETURN ELECTRODE DUAL PLATE WITH CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9913526
• Report Number: 1721194-2020-00030
• Device Sequence Number: 14270855
• Product Code: GEI
• UDI-Device Identifier: 10614559104613
• UDI-Public: 10614559104613
• Combination Product (Y/N): N
• PMA/510(K) Number: K060255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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 Model Number: 0855CN
• Device Catalogue Number: 0855CN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1