MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL; MEGA SOFT UNIVERSAL

Model Number 0845

Device Problems Arcing of Electrodes (2289); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.Investigation summary: the account provided 6 photo images.During the review of the photos, minor damage to the seal and the surface was observed.The damage observed would not have caused the reported event and most likely occurred during use.From the photos, it appears the fire occurred in the materials next to the pad where there are no connectors, cable and no conductive material in the pad.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.Additional information was requested, and the following was obtained: were there any patient consequences related to this complaint? the patient was not operated on due to a burn.What medical intervention was used to treat the burn? (such as salve or stitches) salve, «boltyshka».Are there any anticipated long-term effects from the burn or injury? scar on the lateral surface of the body.What medical intervention was used to treat the burn or injury? (such as salve or stitches) salve, «boltyshka».What is the severity of the burn? superficial burns of incomplete thickness damage the first and second layers of the skin.

Event Description

It was reported that during an unknown procedure a fire broke out during the surgery and the patient got burned (used megasoft during the operation).

• Brand Name: MEGASOFT UNIVERSAL
• Type of Device: MEGA SOFT UNIVERSAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 10472381
• MDR Text Key: 205093228
• Report Number: 1721194-2020-00046
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (y/n): N
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0845
• Device Catalogue Number: 0845
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other