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	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/27/2020.Batch # unknown.Investigation summary: 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.The dhr review of the reported lot number 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.Could you please explain what is the current patient status? how was the injury treated for patient ? will the patient need any follow-up? is this device available to be returned for evaluation? was the pad inspected before use? (e.G.For creases, voids, bubbles, etc.).Location of where the pad was applied on the patient (e.G.Arm, leg, back, etc.).Is there hair or skin folds in the pad applied location? what was the alignment of the pad and cord relative to the surgical site? (e.G.Was the corded side of the pad facing away from the surgical site?) was the patient¿s skin cleaned (e.G.Shaved, alcohol swabbed, etc.) prior to pad placement? was any substance (e.G.Lubricating jelly, conductive gel, etc.) used on or between the grounding pad and the patient¿s skin? was there any moisture under, around, or in the vicinity of the grounding pad that may have seeped between the pad and skin? what was the duration of the surgical procedure? what was the generator model? what was the generator power settings? is a photo of the affected site available? what was the size of the affected site? was the patient laying on the pad? was warming blanket used? how old is the patient? male or female? was the patient's skin dry? was the pad information provided? (e.G.Part number, lot number, etc.).Was the pad removed slowly as described in the instruction? what was the temperature and humidity of the pad stocked environment? response: there is no further information i can provide.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure the hospital was doing a trial on medadyne bovie pads intra-op.The patient had the bi-lateral bovid pads on.At the conclusion of the surgery, the bovie pads were removed and the patient had developed bilateral pinpoint bruising marks at the site and shape of bovie pads that were used during the procedure.No other information was provided.

• 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: 10325982
• Report Number: 1721194-2020-00041
• Device Sequence Number: 2297557
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 0855CN
• Device Catalogue Number: 0855CN
• Device Lot Number: 1810285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1