MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC PEDIATRIC DUAL 9FT CD; RETURN ELECTRODE PEDIATRIC

Catalog Number	0865C
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Following information has been requested but unavailable: what is the age, height and weight of patient? what was between the pad and patient? where was the pad place on patient? was the patient laying on the pad? were there any generator alerts during the procedure? does the patient have any known sensitivities to tape or other adhesives? when was the burn or scar identified and how was it treated? why is it believed that the darkening of the skin noted in the photo is a burn? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A device history record review could not be performed because a valid lot/batch number was not provided.
Event or Problem Description
It was reported that post op of an unknown procedure, it is unknown what occurred possible overheating of the pad.The patient has a burn and a scar from the pad.It is unknown how the patient was treated.

• Brand Name: RTN ELEC PEDIATRIC DUAL 9FT CD
• Common Device Name: RETURN ELECTRODE PEDIATRIC
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 8894075
• Report Number: 1721194-2019-00107
• Device Sequence Number: 1400449
• Product Code: GEI
• UDI-Device Identifier: 10614559102770
• UDI-Public: 10614559102770
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0865C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1
• Patient Weight: 15