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 Codes	Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2021.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.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: the event description stated that the patient was treated with tegaderm.What is the current status of the patient? did the patient have to remain in the hospital longer than expected due to the skin tear? did the patient have to have to have any skin transplants due to this issue? besides the tegaderm how else was the patient treated for the skin tear? does the surgeon believe there is there an alleged deficiency to the pad that led to patient skin tear and if so why? 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 patient stated prior to having surgery that she had very delicate skin and that on a prior surgery she had a large skin tear post op from the surgical drapes.Doctor was made aware of this information.Great care was taken in draping the patient.A bovie pad was placed on the right thigh.The bovie pad (megadyne) currently being used in surgical department is not the usual covidien pad that is normally used.The covidien pads are on backorder.At the end of the procedure, doctor carefully removed the sterile drapes without a skin tear to the patient.Doctor then attempted to remove the bovie pad carefully and the patient ended up receiving a 1" skin tear.The area of skin tear was immediately dressed with a tegaderm.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/18/2021.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.

• 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: 11871712
• Report Number: 1721194-2021-00047
• Device Sequence Number: 13654302
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 0855CN
• Device Catalogue Number: 0855CN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1