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

Model Number	M2K07
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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, the cord of the device had the protective coating peeled off in one area and the wires were exposed.There was no patient consequence reported.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/24/2020.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: 9687742
• Report Number: 1721194-2020-00020
• Device Sequence Number: 14129224
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 01/14/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1