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

Catalog Number	0855CN
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Following information requested but unavailable: please confirm that it was a hematoma (meaning ¿ there was a swelling of clotted blood within the tissues) that was identified and noted by a medical professional? or, was it post-operative bruising? what treatment was administrated to address the hematoma? are there any patient demographics (age, gender, etc.)?.
Event or Problem Description
It was reported that after an unknown procedures that the customer has stated they are having numerous issues with grounding pad from megadyne leaving sticky residue behind, causing bruising upon removal and skin denuding of patients where pad has been placed.Bruising/skin denuding due to adhesive.Customer did share that they slowly removed the pad, using different technique and it appeared that by going slower it drew more blood to top of skin causing more of a hematoma.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/7/2019.Corrected data: upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.Additional information obtained: it was confirmed that the patient did not experience a hematoma, no denuding of the skin and no intervention was required.It was not a pad site burn.It was an elderly patient.Removal caused bruising leaving a triangular mark and a residue of blue substance on the skin.

• 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: 8391769
• Report Number: 1721194-2019-00082
• Device Sequence Number: 11193533
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2019

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: 0855CN
• Initial Date Received by Manufacturer: 02/02/2019
• Supplement Date Received by Manufacturer: 02/02/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/07/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEVICE