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

Model Number	0850C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The device history record review could not be performed because a lot number was not provided by the customer.Additional information was requested, and the following was obtained: is the red mark an allergic reaction to the adhesive? is the red area a burn? if yes for a burn what is the severity of the burn? first degree burns are minor burns on the first layer of skin.Second degree burns have two types: superficial partial-thickness burns injure the first and second layers of skin.Deep partial-thickness burns injure deeper skin layers.Third degree burns injure all the skin layers and tissue under the skin.Are there any anticipated long-term effects from the burn or injury? what medical intervention was used to treat the burn or injury? (such as salve or stitches).Was there any change in the patient care as a result of this event? what is the current patient status? answer: please reach out to the customer for further information as abbott does not have any further information in regards to the event.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: do you have the customers contact information so we can ask some additional information? please provide name and email address.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 atrial fibrillation (afib) procedure, the patient had a red mark where the grounding pad was placed.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/12/2021.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Additional information was requested, and the following was obtained: do you have the customers contact information so we can ask some additional information? please provide name and email address.There is no information available on who to specifically contact at the hospital.

• Brand Name: RTN ELEC SINGLE PLATE 9FT CORD
• Common Device Name: RETURN ELECTRODE SINGLE PLATE WITH CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11725446
• Report Number: 1721194-2021-00030
• Device Sequence Number: 14433661
• Product Code: GEI
• UDI-Device Identifier: 10614559102749
• UDI-Public: 10614559102749
• Combination Product (Y/N): N
• PMA/510(K) Number: K060255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 0850C
• Device Catalogue Number: 0850C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1