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

Model Number	M2K07
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/11/2020.Batch #unk.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 lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, there was a split in the cord where it connects to the megasoft pad and the wires were exposed.No patient involvement occurred.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).H10: corrected data = h1.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.

• Brand Name: MEGASOFT REPLACEMENT CORD
• Common Device Name: MEGA SOFT REPLACEMENT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9696222
• Report Number: 1721194-2020-00021
• Device Sequence Number: 2770551
• Product Code: GEI
• UDI-Device Identifier: 10614559105238
• UDI-Public: 10614559105238
• Combination Product (Y/N): N
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: M2K07
• Device Catalogue Number: M2K07
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEGASOFT UNIVERSAL 185949027.